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, Parathyroid Hormone
510(k) Number K033302
Device Name NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
Applicant
Nichols Institute Diagnostics
1311 Calle Batido
San Clemente,  CA  92673
Applicant Contact JIMMY WONG
Correspondent
Nichols Institute Diagnostics
1311 Calle Batido
San Clemente,  CA  92673
Correspondent Contact JIMMY WONG
Regulation Number862.1545
Classification Product Code
CEW  
Date Received10/14/2003
Decision Date 01/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-