FDA 510(k) Application Details - K810625

Device Classification Name Ng3m(Bo), Antigen, Antiserum, Control

  More FDA Info for this Device
510(K) Number K810625
Device Name Ng3m(Bo), Antigen, Antiserum, Control
Applicant SERONO LABORATORIES, INC.

, US
Other 510(k) Applications for this Company
Regulation Number 866.5065

  More FDA Info for this Regulation Number
Classification Product Code DHI
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 03/09/1981
Decision Date 03/27/1981
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
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