ROCHE COBAS INTEGRA OPIATES 300/2000— 510(k) K992890

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K992890 for ROCHE COBAS INTEGRA OPIATES 300/2000, Substantially Equivalent on 1999-11-23. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DJG
Advisory panel: Clinical Toxicology
Date received: 1999-08-27
Decision date: 1999-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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