Cleared Traditional

AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U

K982759 · OraSure Technologies, Inc. · Toxicology
Nov 1998
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K982759 is an FDA 510(k) clearance for the AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U, 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 November 20, 1998, 106 days after receiving the submission on August 6, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K982759 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 1998
Decision Date November 20, 1998
Days to Decision 106 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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