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B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System

DEN220027 Class II Direct
Decision Date
2023-05-18
Sponsor / Applicant
Brahms GmbH, Part of Thermo Fisher Scientific

Technical Specification

510(k) Submission ID DEN220027
Product Code QWH
Medical Specialty / Panel Clinical Chemistry
Regulation Citation 21 CFR 862.1602
Decision Date 2023-05-18
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System received FDA 510(k) clearance under submission number DEN220027, sponsored by Brahms GmbH, Part of Thermo Fisher Scientific. The device was reviewed via the Direct premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2023-05-18.

Classification & Regulation

This clearance is catalogued under FDA product code QWH and 21 CFR 862.1602, within the Clinical Chemistry review panel as a Class II device.