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 Assay, T Lymphocyte Surface Marker
510(k) Number K914847
Device Name CD8 MONOCLONAL ANTIBODIES
Applicant
Gen Trak, Inc.
5100 Campus Dr.
Plymouth Meeting,  PA  19462
Applicant Contact DEBORAH L.LINDMOUTH
Correspondent
Gen Trak, Inc.
5100 Campus Dr.
Plymouth Meeting,  PA  19462
Correspondent Contact DEBORAH L.LINDMOUTH
Regulation Number864.5220
Classification Product Code
LIZ  
Date Received10/28/1991
Decision Date 06/19/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-