Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K062756
Device Classification Name
Microscope, Automated, Image Analysis, Operator Intervention
More FDA Info for this Device
510(K) Number
K062756
Device Name
Microscope, Automated, Image Analysis, Operator Intervention
Applicant
BIOIMAGENE, INC.
1601 S. DE ANZA BLVD
CUPERTINO, CA 95014 US
Other 510(k) Applications for this Company
Contact
ANNA LONGWELL
Other 510(k) Applications for this Contact
Regulation Number
864.1860
More FDA Info for this Regulation Number
Classification Product Code
NOT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/14/2006
Decision Date
02/20/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact