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 iga, antigen, antiserum, control
510(k) Number K955794
Device Name IGA IMMUNOTURBIDIMETRIC & CALIBRATOR
Applicant
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN,  IE BT29 4QY
Applicant Contact JULIUE TAYLOR
Correspondent
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN,  IE BT29 4QY
Correspondent Contact JULIUE TAYLOR
Regulation Number866.5510
Classification Product Code
CZP  
Date Received12/22/1995
Decision Date 04/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-