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FDA 510(k) Application Details - K040887
Device Classification Name
Antigen, Inflammatory Response Marker, Sepsis
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510(K) Number
K040887
Device Name
Antigen, Inflammatory Response Marker, Sepsis
Applicant
BRAHMS AKTIENGESELLSCHAFT
11800 BALTIMORE AVE.
SUITE 105
BELTSVILLE, MD 20705 US
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Contact
MELISSA MAHALL
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Regulation Number
866.3210
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Classification Product Code
NTM
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Date Received
04/05/2004
Decision Date
01/07/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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