Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K070310
Device Classification Name
Antigen, Inflammatory Response Marker, Sepsis
More FDA Info for this Device
510(K) Number
K070310
Device Name
Antigen, Inflammatory Response Marker, Sepsis
Applicant
BRAHMS AKTIENGESELLSCHAFT
2568A RIVA ROAD
SUITE 207
ANNAPOLIS, MD 21401 US
Other 510(k) Applications for this Company
Contact
JONAS LEICHTNER
Other 510(k) Applications for this Contact
Regulation Number
866.3210
More FDA Info for this Regulation Number
Classification Product Code
NTM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/01/2007
Decision Date
03/31/2008
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact