ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)

Enzyme Immunoassay, Amphetamine

Lin-Zhi International, Inc.

The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Ecstasy Enzyme Immunoassay, Catalog # 0160 (500 Test Kit), Catalog # 0161 (5000 Test Kit).

Pre-market Notification Details

Device IDK033094
510k NumberK033094
Device Name:ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)
ClassificationEnzyme Immunoassay, Amphetamine
Applicant Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale,  CA  94085 -2917
ContactCheng-i Lin
CorrespondentCheng-i Lin
Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale,  CA  94085 -2917
Product CodeDKZ  
Subsequent Product CodeDLJ
Subsequent Product CodeLAS
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-29
Decision Date2003-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B07601680 K033094 000
00811727018007 K033094 000
00811727018014 K033094 000
00811727018021 K033094 000
00811727018038 K033094 000
00811727018045 K033094 000
00811727018052 K033094 000
00811727018069 K033094 000
B07601600 K033094 000
B07601610 K033094 000
B07601620 K033094 000
B07601630 K033094 000
B07601640 K033094 000
B07601650 K033094 000
B07601670 K033094 000
00811727017994 K033094 000

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