FDA 510(k) Application Details - K024062

Device Classification Name Glucose Oxidase, Glucose

  More FDA Info for this Device
510(K) Number K024062
Device Name Glucose Oxidase, Glucose
Applicant BAYER CORP.
1884 MILES AVE.
P.O. BOX 70
ELKHART, IN 46515-0070 US
Other 510(k) Applications for this Company
Contact GEORGE M TANCOS
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 12/09/2002
Decision Date 03/03/2003
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