Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K061536
Device Classification Name
Manual Antimicrobial Susceptibility Test Systems
More FDA Info for this Device
510(K) Number
K061536
Device Name
Manual Antimicrobial Susceptibility Test Systems
Applicant
DADE BEHRING, INC.
2040 ENTERPRISE BLVD.
WEST SACRAMENTO, CA 95691 US
Other 510(k) Applications for this Company
Contact
MAUREEN MENDE
Other 510(k) Applications for this Contact
Regulation Number
866.1640
More FDA Info for this Regulation Number
Classification Product Code
JWY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/02/2006
Decision Date
07/18/2006
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