FDA 510(k) Application Details - K861354

Device Classification Name Radioimmunoassay, Luteinizing Hormone

  More FDA Info for this Device
510(K) Number K861354
Device Name Radioimmunoassay, Luteinizing Hormone
Applicant LEECO DIAGNOSTICS, INC.
21705 EVERGREEN
P.O. BOX 5126
SOUTHFIELD, MI US
Other 510(k) Applications for this Company
Contact LEE, PH.D.
Other 510(k) Applications for this Contact
Regulation Number 862.1485

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

  More FDA Info for this Product Code
Date Received 04/10/1986
Decision Date 09/16/1986
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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