Tina-quant Hemoglobin A1cDx Gen.3

Hemoglobin A1c Test System

Roche Diagnostics Operations (RDO)

The following data is part of a premarket notification filed by Roche Diagnostics Operations (rdo) with the FDA for Tina-quant Hemoglobin A1cdx Gen.3.

Pre-market Notification Details

Device IDK193053
510k NumberK193053
Device Name:Tina-quant Hemoglobin A1cDx Gen.3
ClassificationHemoglobin A1c Test System
Applicant Roche Diagnostics Operations (RDO) 9115 Hague Rd Indianapolis,  IN  46250
ContactLeslie Patterson
CorrespondentLeslie Patterson
Roche Diagnostics Operations (RDO) 9115 Hague Rd Indianapolis,  IN  46250
Product CodePDJ  
CFR Regulation Number862.1373 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-01
Decision Date2020-03-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613336157824 K193053 000

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