Cleared Traditional

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

K090737 · Bio-Rad Laboratories, Inc. · Chemistry
Jun 2009
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K090737 is an FDA 510(k) clearance for the HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Bio-Rad Laboratories, Inc. (Hercules, US). The FDA issued a Cleared decision on June 3, 2009, 75 days after receiving the submission on March 20, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K090737 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2009
Decision Date June 03, 2009
Days to Decision 75 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675

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