Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K960987
Device Classification Name
System, Test, Rheumatoid Factor
More FDA Info for this Device
510(K) Number
K960987
Device Name
System, Test, Rheumatoid Factor
Applicant
BIO-RAD
3726 EAST MIRALOMA AVE.
ANAHEIM, CA 92806 US
Other 510(k) Applications for this Company
Contact
ELIZABETH PLATT
Other 510(k) Applications for this Contact
Regulation Number
866.5775
More FDA Info for this Regulation Number
Classification Product Code
DHR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/11/1996
Decision Date
06/04/1996
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