AGGLUTEX METHAQUALONE TEST KIT— 510(k) K812987

Name: FDA 510(k) clearance K812987
Creator: U.S. Food and Drug Administration
Published: 1981-12-22

Substantially Equivalent

Hoffmann-La Roche, Inc.

FDA 510(k) clearance K812987 for AGGLUTEX METHAQUALONE TEST KIT, Substantially Equivalent on 1981-12-22. Applicant: Hoffmann-La Roche, Inc.. Device class: 2.

Clearance details

Applicant: Hoffmann-La Roche, Inc.
Product code: Code KXS
Device class: Class 2
Regulation: 21 CFR 862.3630
Advisory panel: Clinical Toxicology
Date received: 1981-10-26
Decision date: 1981-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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