Cleared Traditional

TRI-TECH INC. CUSTOM SEXUAL ASSAULT KIT

K922343 · Tri-Tech, Inc. · Toxicology
Feb 1994
Decision
639d
Days
Class 2
Risk

About This 510(k) Submission

K922343 is an FDA 510(k) clearance for the TRI-TECH INC. CUSTOM SEXUAL ASSAULT KIT, 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 February 17, 1994, 639 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 K922343 FDA.gov
FDA Decision Cleared SESK
Date Received May 19, 1992
Decision Date February 17, 1994
Days to Decision 639 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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