TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM

Assay, Glycosylated Hemoglobin

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Tina-quant Hemoglobin A1c Gen.2 Test System.

Pre-market Notification Details

Device IDK072714
510k NumberK072714
Device Name:TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
ClassificationAssay, Glycosylated Hemoglobin
Applicant ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250
ContactTheresa A Bush
CorrespondentTheresa A Bush
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-25
Decision Date2008-04-18
Summary:summary

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