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

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..

Clearance details

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

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