ADVIN MULTI-DRUG SCREEN TEST CASSETTE, DIP CARD AND CUP

Enzyme Immunoassay, Amphetamine

ADVIN BIOTECH

The following data is part of a premarket notification filed by Advin Biotech with the FDA for Advin Multi-drug Screen Test Cassette, Dip Card And Cup.

Pre-market Notification Details

Device IDK122809
510k NumberK122809
Device Name:ADVIN MULTI-DRUG SCREEN TEST CASSETTE, DIP CARD AND CUP
ClassificationEnzyme Immunoassay, Amphetamine
Applicant ADVIN BIOTECH 6861 NANCY RIDGE DR. San Diego,  CA  92121
ContactEdward Tung
CorrespondentEdward Tung
ADVIN BIOTECH 6861 NANCY RIDGE DR. San Diego,  CA  92121
Product CodeDKZ  
Subsequent Product CodeDIO
Subsequent Product CodeDIS
Subsequent Product CodeDJC
Subsequent Product CodeDJG
Subsequent Product CodeDJR
Subsequent Product CodeJXM
Subsequent Product CodeJXN
Subsequent Product CodeLCM
Subsequent Product CodeLDJ
Subsequent Product CodeLFG
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-13
Decision Date2013-06-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B115ABCARDA02031 K122809 000
B115ABCARD11181 K122809 000
B115ABCARD11131 K122809 000
B115ABCARD11071 K122809 000
B115ABCARD11041 K122809 000
B115ABCARD11011 K122809 000
B115ABCARD10341 K122809 000
B115ABCARD10321 K122809 000
B115ABCARD10311 K122809 000
B115ABCARD10301 K122809 000
B115ABCARD10271 K122809 000
B115ABCARD10231 K122809 000
B115ABCARD10201 K122809 000
B115ABCARD10191 K122809 000
B115ABCARD10161 K122809 000
B115ABCARD12011 K122809 000
B115ABCARD12021 K122809 000
B115ABCARDA02021 K122809 000
B115ABCARDA02011 K122809 000
B115ABCARDA01MDMA5001 K122809 000
B115ABCARD14031 K122809 000
B115ABCARD14021 K122809 000
B115ABCARD14011 K122809 000
B115ABCARD13051 K122809 000
B115ABCARD13011 K122809 000
B115ABCARD12211 K122809 000
B115ABCARD12191 K122809 000
B115ABCARD12131 K122809 000
B115ABCARD12101 K122809 000
B115ABCARD12091 K122809 000
B115ABCARD12061 K122809 000
B115ABCARD10141 K122809 000
B115ABCARD10131 K122809 000
B115ABCARD08041 K122809 000
B115ABCARD08011 K122809 000
B115ABCARD07231 K122809 000
B115ABCARD07201 K122809 000
B115ABCARD07141 K122809 000
B115ABCARD07091 K122809 000
B115ABCARD07071 K122809 000
B115ABCARD07061 K122809 000
B115ABCARD07041 K122809 000
B115ABCARD07031 K122809 000
B115ABCARD06291 K122809 000
B115ABCARD06281 K122809 000
B115ABCARD06231 K122809 000
B115ABCARD06221 K122809 000
B115ABCARD08051 K122809 000
B115ABCARD08141 K122809 000
B115ABCARD10121 K122809 000
B115ABCARD10111 K122809 000
B115ABCARD10101 K122809 000
B115ABCARD10091 K122809 000
B115ABCARD10061 K122809 000
B115ABCARD09181 K122809 000
B115ABCARD09171 K122809 000
B115ABCARD09141 K122809 000
B115ABCARD09071 K122809 000
B115ABCARD09061 K122809 000
B115ABCARD09031 K122809 000
B115ABCARD08391 K122809 000
B115ABCARD08291 K122809 000
B115ABCARD08151 K122809 000
B115ABCARD06191 K122809 000
B115ABCARDA11041 K122809 000
B115ABCARDA09071 K122809 000
B115ABCARDA09061 K122809 000
B115ABCARDA09031 K122809 000
B115ABCARDA08151 K122809 000
B115ABCARDA08141 K122809 000
B115ABCARDA08051 K122809 000
B115ABCARDA08041 K122809 000
B115ABCARDA08011 K122809 000
B115ABCARDA07201 K122809 000
B115ABCARDA07141 K122809 000
B115ABCARDA07091 K122809 000
B115ABCARDA07071 K122809 000
B115ABCARDA07061 K122809 000
B115ABCARDA07041 K122809 000
B115ABCARDA10061 K122809 000
B115ABCARDA10091 K122809 000
B115ABCARDA11011 K122809 000
B115ABCARDA10341 K122809 000
B115ABCARDA10311 K122809 000
B115ABCARDA10301 K122809 000
B115ABCARDA10271 K122809 000
B115ABCARDA10231 K122809 000
B115ABCARDA10201 K122809 000
B115ABCARDA10191 K122809 000
B115ABCARDA10161 K122809 000
B115ABCARDA10141 K122809 000
B115ABCARDA10131 K122809 000
B115ABCARDA10121 K122809 000
B115ABCARDA10111 K122809 000
B115ABCARDA10101 K122809 000
B115ABCARDA07031 K122809 000
B115ABCARDA06221 K122809 000
B115ABCARDA05071 K122809 000
B115ABCARDA05041 K122809 000
B115ABCARDA05021 K122809 000
B115ABCARDA05011 K122809 000
B115ABCARDA04111 K122809 000
B115ABCARDA04031 K122809 000
B115ABCARDA04021 K122809 000
B115ABCARDA03071 K122809 000
B115ABCARDA03061 K122809 000
B115ABCARDA03041 K122809 000
B115ABCARDA03031 K122809 000
B115ABCARDA03021 K122809 000
B115ABCARDA03011 K122809 000
B115ABCARDA02051 K122809 000
B115ABCARDA05091 K122809 000
B115ABCARDA05101 K122809 000
B115ABCARDA06191 K122809 000
B115ABCARDA06161 K122809 000
B115ABCARDA06151 K122809 000
B115ABCARDA06111 K122809 000
B115ABCARDA06101 K122809 000
B115ABCARDA06091 K122809 000
B115ABCARDA06081 K122809 000
B115ABCARDA06041 K122809 000
B115ABCARDA06011 K122809 000
B115ABCARDA05231 K122809 000
B115ABCARDA05141 K122809 000
B115ABCARDA05131 K122809 000
B115ABCARDA05121 K122809 000
B115ABCARDA05111 K122809 000
B115ABCARDA02041 K122809 000
B115ABCARD06161 K122809 000
B115ABCARD14041 K122809 000
00858984006347 K122809 000
00858984006330 K122809 000
B115ABCUPC07430 K122809 000
B115ABCARDC07430 K122809 000
B115ABCARD01MET5000 K122809 000
B115ABCUPE12021 K122809 000
B115ABCUPC07031 K122809 000
B115ABCUP12710 K122809 000
B115ABCARDE12021 K122809 000
B115ABCARDC07031 K122809 000
B115ABCARD12710 K122809 000
20850721007949 K122809 000
20850721007932 K122809 000
20850721007857 K122809 000
00850013035038 K122809 000
B115ABCARD05510 K122809 000
B115ABCARD09341 K122809 000
10850013035035 K122809 000
10850013035028 K122809 000
B115ABCUPA11390 K122809 000
B115ABCARDA11390 K122809 000
B115ABCUPC12710 K122809 000
B115ABCUPC12440 K122809 000
B115ABCUP09350 K122809 000
B115ABCUP07460 K122809 000
B115ABCARDC12710 K122809 000
B115ABCARDC12440 K122809 000
B115ABCARD09350 K122809 000
B115ABCARD07460 K122809 000
B115ABCUP05510 K122809 000
20850721007840 K122809 000
20850721007833 K122809 000
B115SECARD05090 K122809 000
B115SECARD01THC500 K122809 000
00850013035182 K122809 000
00850013035199 K122809 000
00858886006803 K122809 000
00850013035205 K122809 000
00850013035304 K122809 000
00858886006827 K122809 000
00858886006834 K122809 000
00850013035502 K122809 000
00840050517536 K122809 000
10840050517526 K122809 000
10840050517496 K122809 000
00850013035519 K122809 000
B115SECARD06100 K122809 000
B115SECARD12020 K122809 000
10850721007829 K122809 000
00850013035137 K122809 000
B115ABCUP11370 K122809 000
B115ABCARD11370 K122809 000
00850721007990 K122809 000
00850013035144 K122809 000
00850013035151 K122809 000
00850013035168 K122809 000
B115APCUP12320 K122809 000
B115APCUP10010 K122809 000
B115APCUPD12740 K122809 000
B115APCUP10260 K122809 000
00850013035175 K122809 000
B115SECUP12020 K122809 000
10840050517519 K122809 000
B115ABCARD06151 K122809 000
B115ABCARD05041 K122809 000
B115ABCARD05021 K122809 000
B115ABCARD05011 K122809 000
B115ABCARD04111 K122809 000
B115ABCARD04031 K122809 000
B115ABCARD04021 K122809 000
B115ABCARD03111 K122809 000
B115ABCARD03071 K122809 000
B115ABCARD03061 K122809 000
B115ABCARD03041 K122809 000
B115ABCARD03031 K122809 000
B115ABCARD03021 K122809 000
B115ABCARD03011 K122809 000
B115ABCARD02051 K122809 000
B115ABCARD05071 K122809 000
B115ABCARD05091 K122809 000
B115ABCARD06111 K122809 000
B115ABCARD06101 K122809 000
B115ABCARD06091 K122809 000
B115ABCARD06081 K122809 000
B115ABCARD06041 K122809 000
B115ABCARD06011 K122809 000
B115ABCARD05391 K122809 000
B115ABCARD05361 K122809 000
B115ABCARD05231 K122809 000
B115ABCARD05141 K122809 000
B115ABCARD05131 K122809 000
B115ABCARD05121 K122809 000
B115ABCARD05111 K122809 000
B115ABCARD05101 K122809 000
B115ABCARD02041 K122809 000
B115ABCARD02031 K122809 000
10850721007928 K122809 000
00858984006262 K122809 000
B115ABCUPE05021 K122809 000
B115ABCUP05451 K122809 000
B115ABCARDE05021 K122809 000
B115ABCARD05451 K122809 000
10850013035011 K122809 000
B115ABCUP11351 K122809 000
B115ABCARD11351 K122809 000
01085072100710 K122809 000
01085072100703 K122809 000
B115ABCUPD12011 K122809 000
B115ABCUP14041 K122809 000
B115ABCUP09341 K122809 000
20850721007888 K122809 000
20850721007895 K122809 000
B115ABCARD02021 K122809 000
B115ABCARD02011 K122809 000
B115ABCARD01THC501 K122809 000
B115ABCARD01OXY1 K122809 000
B115ABCARD01OPI3001 K122809 000
B115ABCARD01OPI20001 K122809 000
B115ABCARD01MDMA5001 K122809 000
B115ABCARD01COC1501 K122809 000
B115ABCARD01BZO3001 K122809 000
B115ABCARD01BUP1 K122809 000
B115ABCARD01AMP5001 K122809 000
B115ABCAR06151 K122809 000
10850721007911 K122809 000
10850721007904 K122809 000
B115ABCARDD12011 K122809 000
B115ABCARDA11071 K122809 000
B313PBCARD01BZO3001 K122809 000
B115ABCUPD05021 K122809 000
B115ABCUPC14011 K122809 000
B115ABCUPC12021 K122809 000
B115ABCUPC10131 K122809 000
B115ABCUPC06081 K122809 000
B115ABCUPC05361 K122809 000
B115ABCUPB12021 K122809 000
B115ABCUPB09071 K122809 000
B115ABCUPA14031 K122809 000
B115ABCUPA14021 K122809 000
B115ABCUPA14011 K122809 000
B115ABCUPA13051 K122809 000
B115ABCUPA13011 K122809 000
B115ABCUPA12211 K122809 000
B115ABCUPD10161 K122809 000
B115ABCUPD12021 K122809 000
B313PBCARD01BAR3001 K122809 000
B313PBCARD01AMP5001 K122809 000
B115ATCUP08011 K122809 000
B115ATCUP07091 K122809 000
B115ATCUP06201 K122809 000
B115ATCUP06011 K122809 000
B115ATCUP05101 K122809 000
B115ATCUP05021 K122809 000
B115ATCARD06011 K122809 000
B115ATCARD05231 K122809 000
B115ATCARD05101 K122809 000
B115ATCARD05021 K122809 000
B115ABCUPH10131 K122809 000
B115ABCUPD12061 K122809 000
B115ABCUPA12191 K122809 000
B115ABCUPA12131 K122809 000
B115ABCUPA10201 K122809 000
B115ABCUPA10191 K122809 000
B115ABCUPA10161 K122809 000
B115ABCUPA10141 K122809 000
B115ABCUPA10131 K122809 000
B115ABCUPA10121 K122809 000
B115ABCUPA10111 K122809 000
B115ABCUPA10101 K122809 000
B115ABCUPA10091 K122809 000
B115ABCUPA10061 K122809 000
B115ABCUPA09071 K122809 000
B115ABCUPA09061 K122809 000
B115ABCUPA09031 K122809 000
B115ABCUPA08151 K122809 000
B115ABCUPA10231 K122809 000
B115ABCUPA10271 K122809 000
B115ABCUPA12101 K122809 000
B115ABCUPA12091 K122809 000
B115ABCUPA12061 K122809 000
B115ABCUPA12021 K122809 000
B115ABCUPA12011 K122809 000
B115ABCUPA11251 K122809 000
B115ABCUPA11181 K122809 000
B115ABCUPA11131 K122809 000
B115ABCUPA11071 K122809 000
B115ABCUPA11041 K122809 000
B115ABCUPA11011 K122809 000
B115ABCUPA10341 K122809 000
B115ABCUPA10311 K122809 000
B115ABCUPA10301 K122809 000
B115ABCUPA08141 K122809 000
00858984006255 K122809 000
B313PBCUP10201 K122809 000
B313PBCUP10061 K122809 000
B313PBCUP10041 K122809 000
B313PBCUP09061 K122809 000
B313PBCUP07091 K122809 000
B313PBCUP06231 K122809 000
B313PBCUP06041 K122809 000
B313PBCUP06011 K122809 000
B313PBCUP05091 K122809 000
B313PBCUP05041 K122809 000
B313PBCUP05021 K122809 000
B313PBCUP04141 K122809 000
B313PBCUP04131 K122809 000
B313PBCUP04091 K122809 000
B313PBCUP10321 K122809 000
B313PBCUP10331 K122809 000
00858984006248 K122809 000
00858984006231 K122809 000
00858984006224 K122809 000
00858984006217 K122809 000
00858984006200 K122809 000
00858984006194 K122809 000
00858984006187 K122809 000
B313PBCUPA12191 K122809 000
B313PBCUPA10321 K122809 000
B313PBCUPA09061 K122809 000
B313PBCUPA05021 K122809 000
B313PBCUP13011 K122809 000
B313PBCUP12191 K122809 000
B313PBCUP12021 K122809 000
B313PBCUP03061 K122809 000
B313PBCUP03041 K122809 000
B313PBCARD06231 K122809 000
B313PBCARD06041 K122809 000
B313PBCARD06011 K122809 000
B313PBCARD05091 K122809 000
B313PBCARD05041 K122809 000
B313PBCARD05021 K122809 000
B313PBCARD04171 K122809 000
B313PBCARD04161 K122809 000
B313PBCARD04091 K122809 000
B313PBCARD03061 K122809 000
B313PBCARD03041 K122809 000
B313PBCARD01THC501 K122809 000
B313PBCARD01PCP1 K122809 000
B313PBCARD01OPI20001 K122809 000
B313PBCARD07091 K122809 000
B313PBCARD09061 K122809 000
B313PBCARDM10201 K122809 000
B313PBCARDAM07251 K122809 000
B313PBCARDA12191 K122809 000
B313PBCARDA10321 K122809 000
B313PBCARDA09061 K122809 000
B313PBCARDA05021 K122809 000
B313PBCARD13011 K122809 000
B313PBCARD12191 K122809 000
B313PBCARD12021 K122809 000
B313PBCARD10331 K122809 000
B313PBCARD10321 K122809 000
B313PBCARD10201 K122809 000
B313PBCARD10061 K122809 000
B313PBCARD10041 K122809 000
B313PBCARD01COC1501 K122809 000
B115ABCUPA08051 K122809 000
B115ABCUP08391 K122809 000
B115ABCUP06231 K122809 000
B115ABCUP06221 K122809 000
B115ABCUP06191 K122809 000
B115ABCUP06161 K122809 000
B115ABCUP06151 K122809 000
B115ABCUP06111 K122809 000
B115ABCUP06101 K122809 000
B115ABCUP06091 K122809 000
B115ABCUP06081 K122809 000
B115ABCUP06041 K122809 000
B115ABCUP06011 K122809 000
B115ABCUP05391 K122809 000
B115ABCUP05361 K122809 000
B115ABCUP05231 K122809 000
B115ABCUP06281 K122809 000
B115ABCUP06291 K122809 000
B115ABCUP08291 K122809 000
B115ABCUP08151 K122809 000
B115ABCUP08141 K122809 000
B115ABCUP08051 K122809 000
B115ABCUP08041 K122809 000
B115ABCUP08011 K122809 000
B115ABCUP07231 K122809 000
B115ABCUP07201 K122809 000
B115ABCUP07141 K122809 000
B115ABCUP07091 K122809 000
B115ABCUP07071 K122809 000
B115ABCUP07061 K122809 000
B115ABCUP07041 K122809 000
B115ABCUP07031 K122809 000
B115ABCUP05101 K122809 000
B115ABCUP05091 K122809 000
B115ABCARDA14021 K122809 000
B115ABCARDA14011 K122809 000
B115ABCARDA13051 K122809 000
B115ABCARDA13011 K122809 000
B115ABCARDA12211 K122809 000
B115ABCARDA12191 K122809 000
B115ABCARDA12131 K122809 000
B115ABCARDA12101 K122809 000
B115ABCARDA12091 K122809 000
B115ABCARDA12061 K122809 000
B115ABCARDA12021 K122809 000
B115ABCARDA12011 K122809 000
B115ABCARDA11251 K122809 000
B115ABCARDA11181 K122809 000
B115ABCARDA14031 K122809 000
B115ABCARDB09071 K122809 000
B115ABCUP05021 K122809 000
B115ABCUP04181 K122809 000
B115ABCUP04031 K122809 000
B115ABCARDH10131 K122809 000
B115ABCARDD12061 K122809 000
B115ABCARDD12021 K122809 000
B115ABCARDD10161 K122809 000
B115ABCARDD05021 K122809 000
B115ABCARDC14011 K122809 000
B115ABCARDC12021 K122809 000
B115ABCARDC10131 K122809 000
B115ABCARDC06081 K122809 000
B115ABCARDC05361 K122809 000
B115ABCARDB12021 K122809 000
B115ABCARDA11131 K122809 000
B115ABCUPA08041 K122809 000
B115ABCUPA06041 K122809 000
B115ABCUPA06011 K122809 000
B115ABCUPA05231 K122809 000
B115ABCUPA05101 K122809 000
B115ABCUPA05091 K122809 000
B115ABCUPA05021 K122809 000
B115ABCUPA04031 K122809 000
B115ABCUP14031 K122809 000
B115ABCUP14021 K122809 000
B115ABCUP14011 K122809 000
B115ABCUP13051 K122809 000
B115ABCUP13011 K122809 000
B115ABCUP12211 K122809 000
B115ABCUP12191 K122809 000
B115ABCUPA06081 K122809 000
B115ABCUPA06091 K122809 000
B115ABCUPA08011 K122809 000
B115ABCUPA07201 K122809 000
B115ABCUPA07141 K122809 000
B115ABCUPA07091 K122809 000
B115ABCUPA07071 K122809 000
B115ABCUPA07061 K122809 000
B115ABCUPA07041 K122809 000
B115ABCUPA07031 K122809 000
B115ABCUPA06221 K122809 000
B115ABCUPA06191 K122809 000
B115ABCUPA06161 K122809 000
B115ABCUPA06151 K122809 000
B115ABCUPA06111 K122809 000
B115ABCUPA06101 K122809 000
B115ABCUP12131 K122809 000
B115ABCUP12101 K122809 000
B115ABCUP10191 K122809 000
B115ABCUP10161 K122809 000
B115ABCUP10141 K122809 000
B115ABCUP10131 K122809 000
B115ABCUP10121 K122809 000
B115ABCUP10111 K122809 000
B115ABCUP10101 K122809 000
B115ABCUP10091 K122809 000
B115ABCUP10061 K122809 000
B115ABCUP09181 K122809 000
B115ABCUP09171 K122809 000
B115ABCUP09141 K122809 000
B115ABCUP09071 K122809 000
B115ABCUP09061 K122809 000
B115ABCUP10201 K122809 000
B115ABCUP10231 K122809 000
B115ABCUP12091 K122809 000
B115ABCUP12061 K122809 000
B115ABCUP12021 K122809 000
B115ABCUP12011 K122809 000
B115ABCUP11181 K122809 000
B115ABCUP11131 K122809 000
B115ABCUP11071 K122809 000
B115ABCUP11041 K122809 000
B115ABCUP11011 K122809 000
B115ABCUP10341 K122809 000
B115ABCUP10321 K122809 000
B115ABCUP10311 K122809 000
B115ABCUP10301 K122809 000
B115ABCUP10271 K122809 000
B115ABCUP09031 K122809 000
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.