ABUSCREEN RADIOIMMUNOASSAY-COCAINE META— 510(k) K830480

Name: FDA 510(k) clearance K830480
Creator: U.S. Food and Drug Administration
Published: 1983-03-24

Substantially Equivalent

Hoffmann-La Roche, Inc.

FDA 510(k) clearance K830480 for ABUSCREEN RADIOIMMUNOASSAY-COCAINE META, Substantially Equivalent on 1983-03-24. Applicant: Hoffmann-La Roche, Inc.. Device class: 2.

Clearance details

Applicant: Hoffmann-La Roche, Inc.
Product code: Code KLN
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1983-02-15
Decision date: 1983-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K910122 — TARGET COCAINE METABOLITE-R1991-03-19

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