ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2— 510(k) K033009

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K033009 for ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2, Substantially Equivalent on 2003-10-16. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code CIX
Advisory panel: Clinical Chemistry
Date received: 2003-09-26
Decision date: 2003-10-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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