IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY— 510(k) K132801

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K132801 for IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY, Substantially Equivalent on 2014-05-28. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code DHB
Advisory panel: Immunology
Date received: 2013-09-13
Decision date: 2014-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.