COBAS INTEGRA CREATININE PLUS VER.2 ASSAY— 510(k) K024098

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K024098 for COBAS INTEGRA CREATININE PLUS VER.2 ASSAY, Substantially Equivalent on 2002-12-19. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JFY
Advisory panel: Clinical Chemistry
Date received: 2002-12-12
Decision date: 2002-12-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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