Name: Predicase
Price: 199 USD

K-number	DEN220027
Device name	B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
Applicant	Brahms GmbH, Part of Thermo Fisher Scientific
Product code	QWH
Device class	Class II
Decision date	May 18, 2023
Decision	Not Substantially Equivalent
Regulation	862.1602

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.