Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K970695
Device Classification Name
System, Test, Immunological, Antigen, Tumor
More FDA Info for this Device
510(K) Number
K970695
Device Name
System, Test, Immunological, Antigen, Tumor
Applicant
CHIRON DIAGNOSTICS CORP.
1401 HARBOR BAY PKWY.
ALAMEDA, CA 94501 US
Other 510(k) Applications for this Company
Contact
DIANE C OATES
Other 510(k) Applications for this Contact
Regulation Number
866.6010
More FDA Info for this Regulation Number
Classification Product Code
MOI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/25/1997
Decision Date
08/08/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact