AGGLUTEX AMPHETAMINE TEST KIT— 510(k) K812986

Name: FDA 510(k) clearance K812986
Creator: U.S. Food and Drug Administration
Published: 1982-01-22

Substantially Equivalent

Hoffmann-La Roche, Inc.

FDA 510(k) clearance K812986 for AGGLUTEX AMPHETAMINE TEST KIT, Substantially Equivalent on 1982-01-22. 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: 1981-10-26
Decision date: 1982-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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