Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Radioimmunoassay, Aldosterone
510(k) Number K050784
Device Name NICHOLS ADVANTAGE ALDOSTERONE ASSAY
Applicant
Nichols Institute Diagnostics
1311 Calle Batido
San Clemente,  CA  92673
Applicant Contact Xie Qiyi
Correspondent
California Department of Health Services
P.O. Box 997 413
Fdb Mailstop 7602
Sacramento,  CA  95899
Regulation Number862.1045
Classification Product Code
CJM  
Date Received03/28/2005
Decision Date 06/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-