AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS 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 Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041 (5000 Tests Kit).

Pre-market Notification Details

Device IDK020395
510k NumberK020395
Device Name:AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)
ClassificationEnzyme Immunoassay, Amphetamine
Applicant Lin-Zhi International, Inc. 2391 ZANKER RD., SUITE 340 San Jose,  CA  95131 -1124
ContactChiu Chin Chang
CorrespondentChiu Chin Chang
Lin-Zhi International, Inc. 2391 ZANKER RD., SUITE 340 San Jose,  CA  95131 -1124
Product CodeDKZ  
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-06
Decision Date2002-06-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B07600410 K020395 000
B07600400 K020395 000
00811727016621 K020395 000
00811727016614 K020395 000

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