COBAS INTEGRA AMIKACIN MAB— 510(k) K991597

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K991597 for COBAS INTEGRA AMIKACIN MAB, Substantially Equivalent on 1999-07-22. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LGJ
Advisory panel: Clinical Toxicology
Date received: 1999-05-10
Decision date: 1999-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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