DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108— 510(k) K081992

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K081992 for DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108, Substantially Equivalent on 2008-08-05. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code MKW
Advisory panel: Clinical Chemistry
Date received: 2008-07-14
Decision date: 2008-08-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Newark, DE, US

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