Cleared Traditional

STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421

K002010 · OraSure Technologies, Inc. · Toxicology
Nov 2000
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K002010 is an FDA 510(k) clearance for the STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421, a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on November 29, 2000, 149 days after receiving the submission on July 3, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K002010 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2000
Decision Date November 29, 2000
Days to Decision 149 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

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

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