COBAS INTEGRA ALP IFCC GEN.2— 510(k) K033185

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K033185 for COBAS INTEGRA ALP IFCC GEN.2, Substantially Equivalent on 2003-10-14. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code CJE
Advisory panel: Clinical Chemistry
Date received: 2003-10-01
Decision date: 2003-10-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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