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 autoantibodies, endomysial(tissue transglutaminase)
510(k) Number K033744
Device Name AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA
Applicant
HYCOR BIOMEDICAL LTD.
PENTLANDS SCIENCE PARK
BUSH LOAN
EDINBURGH,  GB EH26 OPL
Applicant Contact DANIELLE M KNIGHT
Correspondent
HYCOR BIOMEDICAL LTD.
PENTLANDS SCIENCE PARK
BUSH LOAN
EDINBURGH,  GB EH26 OPL
Correspondent Contact DANIELLE M KNIGHT
Regulation Number866.5660
Classification Product Code
MVM  
Date Received12/01/2003
Decision Date 01/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-