Cleared Traditional

TRI-TECH INC. CUSTOM BLOOD ALCOHOL

K922342 · Tri-Tech, Inc. · Toxicology
Aug 1993
Decision
465d
Days
Class 2
Risk

About This 510(k) Submission

K922342 is an FDA 510(k) clearance for the TRI-TECH INC. CUSTOM BLOOD ALCOHOL, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Tri-Tech, Inc. (Durham, US). The FDA issued a Cleared decision on August 27, 1993, 465 days after receiving the submission on May 19, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K922342 FDA.gov
FDA Decision Cleared SEKD
Date Received May 19, 1992
Decision Date August 27, 1993
Days to Decision 465 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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