Cleared Traditional

BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774

K101502 · Becton, Dickinson & CO · Chemistry
Jun 2010
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K101502 is an FDA 510(k) clearance for the BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Becton, Dickinson & CO (Franklin Lakes, US). The FDA issued a Cleared decision on June 29, 2010, 28 days after receiving the submission on June 1, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K101502 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2010
Decision Date June 29, 2010
Days to Decision 28 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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