HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI

Tubes, Vials, Systems, Serum Separators, Blood Collection

BIO-RAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Hemoglobin Capillary Collection System (hccs), 1 Test, Hemoglobin Capillary Collection System (hccs), 5 Tests, Hemoglobi.

Pre-market Notification Details

Device IDK090737
510k NumberK090737
Device Name:HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR Hercules,  CA  94547
ContactJolene Bartilson
CorrespondentJolene Bartilson
BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR Hercules,  CA  94547
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-20
Decision Date2009-06-03
Summary:summary

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