IMMULITE® 2000 Cortisol— 510(k) K202826

Name: FDA 510(k) clearance K202826
Creator: U.S. Food and Drug Administration
Published: 2021-01-15

Substantially Equivalent

Siemens Healthcare Diagnostics Products, Ltd.

FDA 510(k) clearance K202826 for IMMULITE® 2000 Cortisol, Substantially Equivalent on 2021-01-15. Applicant: Siemens Healthcare Diagnostics Products, Ltd.. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics Products, Ltd.
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 2020-09-24
Decision date: 2021-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caerarfon, GB

Download summary PDF View on FDA.gov ↗

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