VARIANT II TURBO HbA1c Kit - 2.0

Hemoglobin A1c Test System

Bio-Rad Laboratories, Inc.

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

Pre-market Notification Details

Device IDK142448
510k NumberK142448
Device Name:VARIANT II TURBO HbA1c Kit - 2.0
ClassificationHemoglobin A1c Test System
Applicant Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Dr. Hercules,  CA  94547
ContactJackie Buckley
CorrespondentJackie Buckley
Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Dr. Hercules,  CA  94547
Product CodePDJ  
CFR Regulation Number862.1373 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-02
Decision Date2015-03-24
Summary:summary

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