VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE

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 Hemoglobin A1c Program (new), Variant Ii Hemoglobin Testing System With Cdm Software, Cdm Software.

Pre-market Notification Details

Device IDK130860
510k NumberK130860
Device Name:VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
ClassificationAssay, Glycosylated Hemoglobin
Applicant BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS 4000 ALFRED NOBEL DRIVE Hercules,  CA  94547
ContactEbony Mckinnies
CorrespondentEbony Mckinnies
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS 4000 ALFRED NOBEL DRIVE Hercules,  CA  94547
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-28
Decision Date2013-04-25
Summary:summary

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