FDA 510(k) Application Details - DEN150009

Device Classification Name

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510(K) Number DEN150009
Device Name B.R.A.H.M.S PCT sensitive KRYPTOR
Applicant B.R.A.H.M.S GMBH
NEUENDORFSTR. 25
HENNIGSDORF 16761 DE
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Contact BERNHARD CIOMMER
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Regulation Number

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Classification Product Code PMT
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Date Received 03/04/2015
Decision Date 02/20/2016
Decision DENG -
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



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