Cleared Traditional

TARGET OPIATES-R

K890978 · V-Tech, Inc. · Toxicology
Nov 1989
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K890978 is an FDA 510(k) clearance for the TARGET OPIATES-R, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by V-Tech, Inc. (Pomona, US). The FDA issued a Cleared decision on November 17, 1989, 263 days after receiving the submission on February 27, 1989. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K890978 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1989
Decision Date November 17, 1989
Days to Decision 263 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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