DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS

Assay, Glycosylated Hemoglobin

MICROGENICS CORP.

The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Dri Hemoglobin A1c Assay And Calibrators.

Pre-market Notification Details

Device IDK053411
510k NumberK053411
Device Name:DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
ClassificationAssay, Glycosylated Hemoglobin
Applicant MICROGENICS CORP. 46360 FREMONT BLVD. Fremont,  CA  94538
ContactTony C Lam
CorrespondentTony C Lam
MICROGENICS CORP. 46360 FREMONT BLVD. Fremont,  CA  94538
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-07
Decision Date2006-02-03
Summary:summary

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