ROCHE ABUSCREEN ONLINE FOR METHAQUALONE— 510(k) K945187

Name: FDA 510(k) clearance K945187
Creator: U.S. Food and Drug Administration
Published: 1995-04-05

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K945187 for ROCHE ABUSCREEN ONLINE FOR METHAQUALONE, Substantially Equivalent on 1995-04-05. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code KXS
Device class: Class 2
Regulation: 21 CFR 862.3630
Advisory panel: Clinical Toxicology
Date received: 1994-10-24
Decision date: 1995-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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