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

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