FDA 510(k) Application Details - K800268

Device Classification Name System, Test, Rheumatoid Factor

  More FDA Info for this Device
510(K) Number K800268
Device Name System, Test, Rheumatoid Factor
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON, DC US
Other 510(k) Applications for this Company
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 02/06/1980
Decision Date 02/21/1980
Decision SE - Substantially Equivalent
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact