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FDA 510(k)

B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC

K-Number: K260302 · 2026-10-23

ApplicantB·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)
Decision Date2026-10-23
Product CodeSJQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM 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 Scientific). It received FDA 510(k) clearance on 2026-10-23 under 510(k) number K260302. The device is classified under product code SJQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC?

B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC is a medical device that received FDA 510(k) clearance on 2026-10-23. The listed applicant is B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific). The 510(k) number is K260302.

When did B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC receive FDA 510(k) clearance?

B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC received FDA 510(k) clearance on 2026-10-23, under 510(k) number K260302.

Who is the listed applicant for B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC?

The FDA 510(k) record lists B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) 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 MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC?

The FDA product code for B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC is SJQ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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