LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL

Control, Hemoglobin, Abnormal

BIO-RAD

The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek(r) Hemoglobin A2 Control.

Pre-market Notification Details

Device IDK911347
510k NumberK911347
Device Name:LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL
ClassificationControl, Hemoglobin, Abnormal
Applicant BIO-RAD 4000 ALFRED NOBEL DR. Hercules,  CA  94547 -1803
ContactSharon K Smith
CorrespondentSharon K Smith
BIO-RAD 4000 ALFRED NOBEL DR. Hercules,  CA  94547 -1803
Product CodeJCM  
CFR Regulation Number864.7415 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-27
Decision Date1991-06-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661002093 K911347 000
00847661000884 K911347 000

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