B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System— 510(k) DEN220027

Name: FDA 510(k) clearance DEN220027
Creator: U.S. Food and Drug Administration
Published: 2023-05-18

Unknown

Brahms GmbH, Part of Thermo Fisher Scientific

FDA 510(k) clearance DEN220027 for B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System, Unknown on 2023-05-18. Applicant: Brahms GmbH, Part of Thermo Fisher Scientific. Device class: 2.

Clearance details

Applicant: Brahms GmbH, Part of Thermo Fisher Scientific
Product code: Code QWH
Device class: Class 2
Regulation: 21 CFR 862.1602
Advisory panel: Clinical Chemistry
Date received: 2022-05-02
Decision date: 2023-05-18
Decision: Unknown
Clearance type: Direct
Location: Hennigsdorf, DE

View on FDA.gov ↗

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