Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K083572
Device Classification Name
System, Blood Culturing
More FDA Info for this Device
510(K) Number
K083572
Device Name
System, Blood Culturing
Applicant
BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS, MD 21152 US
Other 510(k) Applications for this Company
Contact
DENNIS MERTZ
Other 510(k) Applications for this Contact
Regulation Number
866.2560
More FDA Info for this Regulation Number
Classification Product Code
MDB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/03/2008
Decision Date
12/24/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact