Cleared Traditional

VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET

K980414 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry
Mar 1998
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K980414 is an FDA 510(k) clearance for the VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET, 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 March 3, 1998, 28 days after receiving the submission on February 3, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K980414 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1998
Decision Date March 03, 1998
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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