DIMENSION VISA ENZ 2 CAL— 510(k) K103612

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K103612 for DIMENSION VISA ENZ 2 CAL, Substantially Equivalent on 2011-01-25. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 2010-12-09
Decision date: 2011-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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