• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name radioimmunoassay, human growth hormone
510(k) Number K951707
Device Name DSL ACTIVE IFGBP-3 ELISA
Original Applicant
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 medical center blvd.
webster,  TX  77598
Original Contact john willis
Regulation Number862.1370
Classification Product Code
CFL  
Date Received04/13/1995
Decision Date 05/10/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-