FDA 510(k) Application Details - K050784

Device Classification Name Radioimmunoassay, Aldosterone

  More FDA Info for this Device
510(K) Number K050784
Device Name Radioimmunoassay, Aldosterone
Applicant NICHOLS INSTITUTE DIAGNOSTICS
1311 CALLE BATIDO
SAN CLEMENTE, CA 92673 US
Other 510(k) Applications for this Company
Contact Xie Qiyi
Other 510(k) Applications for this Contact
Regulation Number 862.1045

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

  More FDA Info for this Product Code
Date Received 03/28/2005
Decision Date 06/01/2005
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 Y
Expedited Review



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