Cleared Traditional

MICRO-PLATE COTININE EIA

K974234 · OraSure Technologies, Inc. · Toxicology
May 1998
Decision
183d
Days
Class 1
Risk

About This 510(k) Submission

K974234 is an FDA 510(k) clearance for the MICRO-PLATE COTININE EIA, a Enzyme Immunoassay, Nicotine And Nicotine Metabolites (Class I — General Controls, product code MKU), submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on May 14, 1998, 183 days after receiving the submission on November 12, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3220.

Submission Details

510(k) Number K974234 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1997
Decision Date May 14, 1998
Days to Decision 183 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code MKU — Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3220

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