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 K921787
Device Name SYNELISA TPO ANTIBODIES
Applicant
Elias U.S.A., Inc.
373 280th St.
Osceola,  WI  54020
Applicant Contact GOTTFRIED KELLERMANN
Correspondent
Elias U.S.A., Inc.
373 280th St.
Osceola,  WI  54020
Correspondent Contact GOTTFRIED KELLERMANN
Regulation Number866.5870
Classification Product Code
JNL  
Date Received04/14/1992
Decision Date 07/28/1992
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
-
-