COBAS 8000 MODULAR SERIES ANALYZER— 510(k) K100853

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K100853 for COBAS 8000 MODULAR SERIES ANALYZER, Substantially Equivalent on 2010-09-09. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DCF
Advisory panel: Immunology
Date received: 2010-03-26
Decision date: 2010-09-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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