MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)— 510(k) K033501

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K033501 for MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS), Substantially Equivalent on 2003-11-20. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 2003-11-05
Decision date: 2003-11-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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