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 Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K952253
Device Name ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT
Applicant
Helix Diagnostics, Inc.
3148 Industrial Blvd.
West Sacramento,  CA  95691
Applicant Contact VIRGINIA L CAPPEL
Correspondent
Helix Diagnostics, Inc.
3148 Industrial Blvd.
West Sacramento,  CA  95691
Correspondent Contact VIRGINIA L CAPPEL
Regulation Number866.5100
Classification Product Code
LLL  
Date Received05/15/1995
Decision Date 08/24/1995
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
-
-