Cleared Traditional

TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER

K971111 · Tri-Tech, Inc. · Chemistry
Jun 1997
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K971111 is an FDA 510(k) clearance for the TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Tri-Tech, Inc. (Southport, US). The FDA issued a Cleared decision on June 16, 1997, 82 days after receiving the submission on March 26, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K971111 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1997
Decision Date June 16, 1997
Days to Decision 82 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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