FDA 510(k) Application Details - K070820

Device Classification Name Enzyme Immunoassay, Tracrolimus

  More FDA Info for this Device
510(K) Number K070820
Device Name Enzyme Immunoassay, Tracrolimus
Applicant FUJIREBIO DIAGNOSTICS, INC.
201 GREAT VALLEY PKWY.
MALVERN, PA 19355-1307 US
Other 510(k) Applications for this Company
Contact DIANA DICKSON
Other 510(k) Applications for this Contact
Regulation Number 862.1678

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

  More FDA Info for this Product Code
Date Received 03/26/2007
Decision Date 08/01/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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