Cleared Traditional

VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE

K991551 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry
Sep 1999
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K991551 is an FDA 510(k) clearance for the VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE, 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 September 23, 1999, 143 days after receiving the submission on May 3, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K991551 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1999
Decision Date September 23, 1999
Days to Decision 143 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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