Cleared Traditional

K921806 - VACUTAINER(R) BRAND SST(R) AND CAT TUBES (FDA 510(k) Clearance)

K921806 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device

Apr 1992

Decision

14d

Days

Class 2

Risk

K921806 is an FDA 510(k) clearance for the VACUTAINER(R) BRAND SST(R) AND CAT TUBES. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on April 29, 1992, 14 days after receiving the submission on April 15, 1992.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number	K921806 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 15, 1992
Decision Date	April 29, 1992
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement