DeviceClearance

IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material— 510(k) K152061

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K152061 for IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material, Substantially Equivalent on 2016-03-03. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant
Siemens Healthcare Diagnostics, Inc.
Product code
Code JZO
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tarrytown, NY, US
Download summary PDFView on FDA.gov ↗

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