Cleared Traditional

SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV

K974374 · Ohmeda Medical · Chemistry
Jan 1998
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K974374 is an FDA 510(k) clearance for the SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Ohmeda Medical (Murray Hill, US). The FDA issued a Cleared decision on January 2, 1998, 43 days after receiving the submission on November 20, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K974374 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 1997
Decision Date January 02, 1998
Days to Decision 43 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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