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, Systemic Lupus Erythematosus
510(k) Number K790106
Device Name IIF-A-N-DNA TEST KIT
Applicant
Medica Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medica Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5820
Classification Product Code
DHC  
Date Received01/18/1979
Decision Date 03/15/1979
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
-
-