FDA 510(k) Application Details - K963734

Device Classification Name Electrode, Ion-Specific, Chloride

  More FDA Info for this Device
510(K) Number K963734
Device Name Electrode, Ion-Specific, Chloride
Applicant ALKO DIAGNOSTIC CORP.
333 FISKE ST.
HOLLISTON, MA 01746 US
Other 510(k) Applications for this Company
Contact JANET A MCGRATH
Other 510(k) Applications for this Contact
Regulation Number 862.1170

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

  More FDA Info for this Product Code
Date Received 08/29/1996
Decision Date 10/24/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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