D-100 HbA1c, D-100 HbA1c Calibrator Pack

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 D-100 Hba1c, D-100 Hba1c Calibrator Pack.

Pre-market Notification Details

Device IDK151321
510k NumberK151321
Device Name:D-100 HbA1c, D-100 HbA1c Calibrator Pack
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  
Subsequent Product CodeJIT
Subsequent Product CodeLCP
CFR Regulation Number862.1373 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-18
Decision Date2015-12-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847817025693 K151321 000
00847817025679 K151321 000
00847817020155 K151321 000
00847817016035 K151321 000
00847817016028 K151321 000
00847817016004 K151321 000
00847817015991 K151321 000
00847817015953 K151321 000

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