Name: Predicase
Price: 199 USD

K-number	K222251
Device name	B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC
Applicant	B.R.A.H.M.S GmbH, Part of Thermo Fisher
Product code	QXS
Device class	Class II
Decision date	Sep 18, 2023
Decision	Substantially Equivalent
Regulation	866.6010

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Source

View the full FDA submission: accessdata.fda.gov

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B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC

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