FDA 510(k) Application Details - K022200

Device Classification Name Counter, Differential Cell

  More FDA Info for this Device
510(K) Number K022200
Device Name Counter, Differential Cell
Applicant ABX DIAGNOSTICS
PARC EUROMEDECINE
RUE DU CADUCEE
MONPELLIER 34184 FR
Other 510(k) Applications for this Company
Contact TIM LAWTON
Other 510(k) Applications for this Contact
Regulation Number 864.5220

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

  More FDA Info for this Product Code
Date Received 07/05/2002
Decision Date 07/29/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HE - Hematology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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