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 Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
510(k) Number K994071
Device Name RHIGENE ANA ELISA TEST SYSTEM
Applicant
Rhigene, Inc.
455 State St.,
Suite 104
Des Plaines,  IL  60068
Applicant Contact DAVE KOLESAR
Correspondent
Rhigene, Inc.
455 State St.,
Suite 104
Des Plaines,  IL  60068
Correspondent Contact DAVE KOLESAR
Regulation Number866.5100
Classification Product Code
LJM  
Date Received12/02/1999
Decision Date 01/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-