Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K092953
Device Classification Name
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
More FDA Info for this Device
510(K) Number
K092953
Device Name
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Applicant
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE, CA 94089-1189 US
Other 510(k) Applications for this Company
Contact
RUSSEL K ENNS
Other 510(k) Applications for this Contact
Regulation Number
866.1640
More FDA Info for this Regulation Number
Classification Product Code
NIJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/24/2009
Decision Date
12/17/2009
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