DIMENSION VISA HBA1C, MODEL K3105A— 510(k) K102045

Substantially Equivalent

Siemens Heatlhcare Diagnostics, Inc.

FDA 510(k) clearance K102045 for DIMENSION VISA HBA1C, MODEL K3105A, Substantially Equivalent on 2011-02-14. Applicant: Siemens Heatlhcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Heatlhcare Diagnostics, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2010-07-21
Decision date: 2011-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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