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FDA 510(k)

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

Número K: K222251 · 2023-09-18

RequerenteB.R.A.H.M.S GmbH, Part of Thermo Fisher
Data da decisão2023-09-18
Código do produtoQXS
Comité consultivoIM
DecisãoSubstantially Equivalent

Resumo do dispositivo

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 is the device name listed in this FDA 510(k) record. The listed applicant is B.R.A.H.M.S GmbH, Part of Thermo Fisher. It received FDA 510(k) clearance on 2023-09-18 under 510(k) number K222251. The device is classified under product code QXS. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 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?

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 is a medical device that received FDA 510(k) clearance on 2023-09-18. The listed applicant is B.R.A.H.M.S GmbH, Part of Thermo Fisher. The 510(k) number is K222251.

When did 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 receive FDA 510(k) clearance?

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 received FDA 510(k) clearance on 2023-09-18, under 510(k) number K222251.

Who is the listed applicant for 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?

The FDA 510(k) record lists B.R.A.H.M.S GmbH, Part of Thermo Fisher as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 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?

The FDA product code for 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 is QXS.

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