FDA 510(k) Application Details - K060929

Device Classification Name Radioassay, Vitamin B12

  More FDA Info for this Device
510(K) Number K060929
Device Name Radioassay, Vitamin B12
Applicant DIAGNOSTIC PRODUCTS CORPORATION
5210 PACIFIC CONCOURSE DR.
LOS ANGELES, CA 90045-6900 US
Other 510(k) Applications for this Company
Contact DEBORAH L MORRIS
Other 510(k) Applications for this Contact
Regulation Number 862.1810

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

  More FDA Info for this Product Code
Date Received 04/05/2006
Decision Date 04/28/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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