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 Immunochemical, Thyroglobulin Autoantibody
510(k) Number K905486
Device Name IMMUNOWELL TPO (MICROSOME) TEST
Applicant
General Biometrics, Inc.
15222 Ave. Of Science
Suite A
San Diego,  CA  92128
Applicant Contact BRYAN L KIEHL
Correspondent
General Biometrics, Inc.
15222 Ave. Of Science
Suite A
San Diego,  CA  92128
Correspondent Contact BRYAN L KIEHL
Regulation Number866.5870
Classification Product Code
JNL  
Date Received12/06/1990
Decision Date 01/03/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-