FDA cleared 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 from B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) on Oct 23, 2026 under K260302, a traditional 510(k). The review panel was Microbiology.
FDA logged the submission as received on Jan 30, 2026. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
This is the only decision on file for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K260302?
K260302 is the FDA 510(k) 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, submitted by B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific). FDA's decision date was Oct 23, 2026, under product code SJQ.
Who makes 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 GmbH (part of Thermo Fisher Scientific), based in Hennigsdorf, is the applicant of record for K260302.
How long did the K260302 review take?
FDA received the submission on Jan 30, 2026 and issued its decision on Oct 23, 2026, 266 days later.