ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)— 510(k) K991443

Name: FDA 510(k) clearance K991443
Creator: U.S. Food and Drug Administration
Published: 1999-06-22

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K991443 for ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ), Substantially Equivalent on 1999-06-22. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JXM
Device class: Class 2
Regulation: 21 CFR 862.3170
Advisory panel: Clinical Toxicology
Date received: 1999-04-26
Decision date: 1999-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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