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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K260302
Device Name 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
Applicant
B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)
Neuendorfstrasse 25
Hennigsdorf,  DE 16761
Applicant Contact Anja Jagalla
Correspondent
B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)
Neuendorfstrasse 25
Hennigsdorf,  DE 16761
Correspondent Contact Anja Jagalla
Classification Product Code
SJQ
Subsequent Product Codes
JIT   JJX  
Date Received01/30/2026
Decision Date 10/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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