510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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DEN220027Unknown

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

Brahms GmbH, Part of Thermo Fisher Scientific, Hennigsdorf, DE / Direct, Unknown
FDA source (opens on fda.gov)

DEN220027 is the FDA 510(k) clearance record for B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System, a class II device, cleared for Brahms GmbH, Part of Thermo Fisher Scientific on under FDA product code QWH (Prognostic Test For Development Or Progression Of Preeclampsia). FDA's definition for product code QWH reads: "A prognostic test for development or progression of preeclampsia is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples. A prognostic test for development or progression of preeclampsia is...". FDA records list one 510(k) clearance for Brahms GmbH, Part of Thermo Fisher Scientific. As of , FDA records show no recalls naming DEN220027.

Clearance record

Decision date
Received
(381 days to decision)
Product code
QWH Prognostic Test For Development Or Progression Of Preeclampsia
Regulation
21 CFR 862.1602
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Brahms GmbH, Part of Thermo Fisher Scientific Neuensdorfstrasse 25, Hennigsdorf, DE
Third party review
No

Clearances, product code QWH

Trailing 12 months

FDA records hold no clearances under product code QWH in the trailing twelve months.

FDA records show no clearances under product code QWH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QWH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260