Cleared Traditional

K091292 - BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 (FDA 510(k) Clearance)

K091292 · Becton, Dickinson and Company (BD) · Chemistry device

Aug 2009

Decision

113d

Days

Class 2

Risk

K091292 is an FDA 510(k) clearance for the BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771. This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number	K091292 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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