BENZODIAZEPINE ENZYME IMMUNOASSAY

Enzyme Immunoassay, Benzodiazepine

Lin-Zhi International, Inc.

The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Benzodiazepine Enzyme Immunoassay.

Pre-market Notification Details

Device IDK032365
510k NumberK032365
Device Name:BENZODIAZEPINE ENZYME IMMUNOASSAY
ClassificationEnzyme Immunoassay, Benzodiazepine
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 CodeJXM  
Subsequent Product CodeDLJ
Subsequent Product CodeLAS
CFR Regulation Number862.3170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-31
Decision Date2003-09-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B07601360 K032365 000
00811727017116 K032365 000
00811727017123 K032365 000
00811727017130 K032365 000
00811727017147 K032365 000
00811727017154 K032365 000
00811727017161 K032365 000
B07601300 K032365 000
B07601310 K032365 000
B07601320 K032365 000
B07601330 K032365 000
B07601340 K032365 000
B07601350 K032365 000
00811727017109 K032365 000

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