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 Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K973208
Device Name FIRST SIGN
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 Number862.1155
Classification Product Code
LCX  
Date Received08/27/1997
Decision Date 10/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-