FDA 510(k) Application Details - K982328

Device Classification Name Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes

  More FDA Info for this Device
510(K) Number K982328
Device Name Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Applicant BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN, NY 10591-5097 US
Other 510(k) Applications for this Company
Contact GABRIEL J MURACA JR.
Other 510(k) Applications for this Contact
Regulation Number 862.1050

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

  More FDA Info for this Product Code
Date Received 07/02/1998
Decision Date 01/29/1999
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