IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT— 510(k) K112523

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K112523 for IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, Substantially Equivalent on 2012-01-06. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code DHB
Advisory panel: Immunology
Date received: 2011-08-31
Decision date: 2012-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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