IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA— 510(k) K213510

Substantially Equivalent

Siemens Healthcare Diagnostics Products, Ltd.

FDA 510(k) clearance K213510 for IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA, Substantially Equivalent on 2023-09-08. Applicant: Siemens Healthcare Diagnostics Products, Ltd..

Clearance details

Applicant: Siemens Healthcare Diagnostics Products, Ltd.
Product code: Code LTK
Advisory panel: Immunology
Date received: 2021-11-02
Decision date: 2023-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Llanberis, GB

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