Cleared Traditional

STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)

K982061 · OraSure Technologies, Inc. · Toxicology
Aug 1998
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K982061 is an FDA 510(k) clearance for the STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE), a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on August 25, 1998, 82 days after receiving the submission on June 4, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K982061 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 1998
Decision Date August 25, 1998
Days to Decision 82 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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