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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Procalcitonin Assay
510(k) Number K171338
Device Name B R A H M S PCT sensitive KRYPTOR
Applicant
B.R.A.H.M.S GmbH
Neuendorfstr. 25
Hennigsdorf,  DE 16761
Applicant Contact Sascha Johannes
Correspondent
B.R.A.H.M.S GmbH
Neuendorfstr. 25
Hennigsdorf,  DE 16761
Correspondent Contact Bernhard Ciommer
Regulation Number866.3215
Classification Product Code
PRI  
Subsequent Product Codes
NTM   PMT  
Date Received05/08/2017
Decision Date 05/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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