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 Calibrator, Secondary
510(k) Number K012367
Device Name VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D
Applicant
Nichols Institute Diagnostics
33047 Calle Aviador
San Juan Capistrano,  CA  92675
Applicant Contact JIMMY WONG
Correspondent
Nichols Institute Diagnostics
33047 Calle Aviador
San Juan Capistrano,  CA  92675
Correspondent Contact JIMMY WONG
Regulation Number862.1150
Classification Product Code
JIT  
Subsequent Product Codes
JJX   MRG  
Date Received07/26/2001
Decision Date 10/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-