OPIATE ENZYME IMMUNOASSAY

Enzyme Immunoassay, Opiates

Lin-Zhi International, Inc.

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

Pre-market Notification Details

Device IDK110298
510k NumberK110298
Device Name:OPIATE ENZYME IMMUNOASSAY
ClassificationEnzyme Immunoassay, Opiates
Applicant Lin-Zhi International, Inc. 670 ALmanor Avenue Sunnyvale,  CA  94085
ContactBernice Lin
CorrespondentBernice Lin
Lin-Zhi International, Inc. 670 ALmanor Avenue Sunnyvale,  CA  94085
Product CodeDJG  
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-01
Decision Date2011-07-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B0760021B0 K110298 000
B0760020B0 K110298 000
00811727016874 K110298 000
00811727016867 K110298 000

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