BIO-RAD VARIANT NBS SICKLE CELL PROGRAM

Abnormal Hemoglobin Quantitation

BIO-RAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Bio-rad Variant Nbs Sickle Cell Program.

Pre-market Notification Details

Device IDK051072
510k NumberK051072
Device Name:BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
ClassificationAbnormal Hemoglobin Quantitation
Applicant BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR. Hercules,  CA  94547
ContactWilliam G Gustafson
CorrespondentAlfred J Quattrone
CALIFORNIA DEPARTMENT OF HEALTH SERVICES P.O. BOX 997 413 FDB MAILSTOP 7602 Sacramento,  CA  95899 -7413
Product CodeGKA  
CFR Regulation Number864.7415 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-04-26
Decision Date2005-05-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847817008351 K051072 000
00847817008344 K051072 000
00847817008313 K051072 000
00847817008306 K051072 000
00847817008283 K051072 000
00847817008276 K051072 000
00847817007354 K051072 000

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