BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS

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 Buprenorphine Enzyme Immunoassay, Calibrators And Controls For Beckman Coulter Synchron Systems.

Pre-market Notification Details

Device IDK081008
510k NumberK081008
Device Name:BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
ClassificationEnzyme Immunoassay, Opiates
Applicant Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale,  CA  94085 -2917
ContactMarie Lin
CorrespondentMarie Lin
Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale,  CA  94085 -2917
Product CodeDJG  
Subsequent Product CodeDLJ
Subsequent Product CodeLAS
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-10
Decision Date2008-12-22
Summary:summary

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