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 C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K890423
Device Name V-TREND TARGET CRP TEST
Applicant
TEXAS IMMUNOLOGY, INC.
5400 SPUR 248
TYLER,  TX  75707
Applicant Contact CHARLES W GILL
Correspondent
TEXAS IMMUNOLOGY, INC.
5400 SPUR 248
TYLER,  TX  75707
Correspondent Contact CHARLES W GILL
Regulation Number866.5270
Classification Product Code
DCK  
Date Received01/26/1989
Decision Date 02/17/1989
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
-
-