LABONE COCAINE METABOLITE MICRO-PLATE EIA— 510(k) K040198

Name: FDA 510(k) clearance K040198
Creator: U.S. Food and Drug Administration
Published: 2004-03-05

Substantially Equivalent

Labone, Inc.

FDA 510(k) clearance K040198 for LABONE COCAINE METABOLITE MICRO-PLATE EIA, Substantially Equivalent on 2004-03-05. Applicant: Labone, Inc.. Device class: 2.

Clearance details

Applicant: Labone, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2004-01-29
Decision date: 2004-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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