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 System, Test, Thyroglobulin
510(k) Number K994140
Device Name NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240
Applicant
Nichols Institute Diagnostics
33051 Calle Aviador
San Juan Capistrano,  CA  92675
Applicant Contact JIMMY WONG
Correspondent
Nichols Institute Diagnostics
33051 Calle Aviador
San Juan Capistrano,  CA  92675
Correspondent Contact JIMMY WONG
Regulation Number866.6010
Classification Product Code
MSW  
Date Received12/08/1999
Decision Date 05/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-