Cleared Traditional

MICRO-PLATE COTININE EIA

K974534 · OraSure Technologies, Inc. · Toxicology
May 1998
Decision
167d
Days
Class 1
Risk

About This 510(k) Submission

K974534 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 18, 1998, 167 days after receiving the submission on December 2, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3220.

Submission Details

510(k) Number K974534 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 1997
Decision Date May 18, 1998
Days to Decision 167 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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