Cleared Traditional

TARGET COCAINE METABOLITE-R

K910122 · V-Tech, Inc. · Immunology
Mar 1991
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K910122 is an FDA 510(k) clearance for the TARGET COCAINE METABOLITE-R, a Radioimmunoassay, Cocaine Metabolite (Class II — Special Controls, product code KLN), submitted by V-Tech, Inc. (El Monte, US). The FDA issued a Cleared decision on March 19, 1991, 67 days after receiving the submission on January 11, 1991. This device falls under the Immunology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K910122 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 1991
Decision Date March 19, 1991
Days to Decision 67 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code KLN — Radioimmunoassay, Cocaine Metabolite
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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