ADVIA Centaur Cortisol (COR)— 510(k) K192788

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K192788 for ADVIA Centaur Cortisol (COR), Substantially Equivalent on 2019-11-25. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant
Siemens Healthcare Diagnostics, Inc.
Product code
Code JFT
Device class
Class 2
Regulation
21 CFR 862.1205
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tarrytown, NY, US
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