Cleared Traditional

METHADONE EIA ASSAY

K972526 · Diagnostic Reagents, Inc. · Toxicology
Aug 1997
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K972526 is an FDA 510(k) clearance for the METHADONE EIA ASSAY, a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 4, 1997, 39 days after receiving the submission on June 26, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K972526 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1997
Decision Date August 04, 1997
Days to Decision 39 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DJR — Enzyme Immunoassay, Methadone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3620

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