ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE— 510(k) K830482

Name: FDA 510(k) clearance K830482
Creator: U.S. Food and Drug Administration
Published: 1983-03-24

Substantially Equivalent

Hoffmann-La Roche, Inc.

FDA 510(k) clearance K830482 for ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE, Substantially Equivalent on 1983-03-24. Applicant: Hoffmann-La Roche, Inc.. Device class: 2.

Clearance details

Applicant: Hoffmann-La Roche, Inc.
Product code: Code DJP
Device class: Class 2
Regulation: 21 CFR 862.3100
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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K830461 — ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE1983-03-24
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