STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)— 510(k) K982061

Name: FDA 510(k) clearance K982061
Creator: U.S. Food and Drug Administration
Published: 1998-08-25

Substantially Equivalent

OraSure Technologies, Inc.

FDA 510(k) clearance K982061 for STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE), Substantially Equivalent on 1998-08-25. 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: 1998-06-04
Decision date: 1998-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K982061

K-number listed on FDA's recall record

Z-1419-2018 — Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000Class III·Terminated·OraSure Technologies, Inc.·20171220

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982061.

Data sourced from openFDA. This site is unofficial and independent of the FDA.