Cleared Traditional

AUTO-LYTE COTININE EIA

K972481 · OraSure Technologies, Inc. · Toxicology
Oct 1997
Decision
111d
Days
Class 1
Risk

About This 510(k) Submission

K972481 is an FDA 510(k) clearance for the AUTO-LYTE 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 October 21, 1997, 111 days after receiving the submission on July 2, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3220.

Submission Details

510(k) Number K972481 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1997
Decision Date October 21, 1997
Days to Decision 111 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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