FDA 510(k) Application Details - K024080

Device Classification Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

  More FDA Info for this Device
510(K) Number K024080
Device Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Applicant PERFUSION PARTNERS & ASSOC. INC.
P.O. BOX 4341
CROFTON, MD 21114 US
Other 510(k) Applications for this Company
Contact E.J. Smith
Other 510(k) Applications for this Contact
Regulation Number 862.2050

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

  More FDA Info for this Product Code
Date Received 12/10/2002
Decision Date 07/02/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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