K081992

Substantially Equivalent

DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108

Applicant: Siemens Healthcare Diagnostics, Inc.
Product 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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