Cleared Traditional

BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771

K091292 · Becton, Dickinson and Company (BD) · Chemistry
Aug 2009
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K091292 is an FDA 510(k) clearance for the BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Becton, Dickinson and Company (BD) (Franklin Lakes, US). The FDA issued a Cleared decision on August 25, 2009, 113 days after receiving the submission on May 4, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K091292 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2009
Decision Date August 25, 2009
Days to Decision 113 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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