FDA 510(k) Application Details - K014024

Device Classification Name Immunoassay Method, Troponin Subunit

  More FDA Info for this Device
510(K) Number K014024
Device Name Immunoassay Method, Troponin Subunit
Applicant FIRST MEDICAL, INC.
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
Other 510(k) Applications for this Company
Contact GREG HOLLAND
Other 510(k) Applications for this Contact
Regulation Number 862.1215

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

  More FDA Info for this Product Code
Date Received 12/06/2001
Decision Date 12/18/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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