• 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 immunoelectrophoretic, immunoglobulins, (g, a, m)
510(k) Number K120169
Device Name INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
Original Applicant
GRIFOLS USA, LLC
482 cherry lane rd.
east stroudsburg,  PA  18301
Original Contact gary lehnus
Regulation Number866.5510
Classification Product Code
CFF  
Subsequent Product Codes
CEF   DEH   DFH  
Date Received01/19/2012
Decision Date 08/24/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-