VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM

Assay, Glycosylated Hemoglobin

BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS

The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc., Clinical Systems Divis with the FDA for Variant Ii Turbo Hba1c Kit-2.0 Variant Ii Turbo Hemoglobin Testing System.

Pre-market Notification Details

Device IDK122472
510k NumberK122472
Device Name:VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
ClassificationAssay, Glycosylated Hemoglobin
Applicant BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS 4000 ALFRED NOBEL DRIVE Hercules,  CA  94547
ContactJackie Buckley
CorrespondentJackie Buckley
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS 4000 ALFRED NOBEL DRIVE Hercules,  CA  94547
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-14
Decision Date2012-10-26
Summary:summary

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