Cleared Special

ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000

K992422 · Princeton BioMeditech Corp. · Toxicology
Aug 1999
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K992422 is an FDA 510(k) clearance for the ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on August 10, 1999, 20 days after receiving the submission on July 21, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K992422 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1999
Decision Date August 10, 1999
Days to Decision 20 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

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