FDA 510(k) Application Details - K964630

Device Classification Name Glucose Oxidase, Glucose

  More FDA Info for this Device
510(K) Number K964630
Device Name Glucose Oxidase, Glucose
Applicant BAYER CORP.
1884 MILES AVE.
P.O. BOX 70
ELKHART, IN 46514-0070 US
Other 510(k) Applications for this Company
Contact ROSANNE M SAVOL
Other 510(k) Applications for this Contact
Regulation Number 862.1345

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

  More FDA Info for this Product Code
Date Received 11/19/1996
Decision Date 02/10/1997
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