COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA— 510(k) K001197

Name: FDA 510(k) clearance K001197
Creator: U.S. Food and Drug Administration
Published: 2000-05-11

Substantially Equivalent

OraSure Technologies, Inc.

FDA 510(k) clearance K001197 for COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA, Substantially Equivalent on 2000-05-11. Applicant: OraSure Technologies, Inc.. Device class: 2.

Clearance details

Applicant: OraSure Technologies, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2000-04-11
Decision date: 2000-05-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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