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 System, Test, Infectious Mononucleosis
510(k) Number K864207
Device Name DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO
Applicant
Gamma Biologicals, Inc.
3700 Mangum Rd., #451-M
Houston,  TX  77092
Applicant Contact JOHN CASE
Correspondent
Gamma Biologicals, Inc.
3700 Mangum Rd., #451-M
Houston,  TX  77092
Correspondent Contact JOHN CASE
Regulation Number866.5640
Classification Product Code
KTN  
Date Received10/27/1986
Decision Date 12/03/1986
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
-
-