DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306— 510(k) K081857

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K081857 for DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306, Substantially Equivalent on 2008-10-30. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code NRP
Advisory panel: Clinical Toxicology
Date received: 2008-07-01
Decision date: 2008-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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