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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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