• 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 kappa, antigen, antiserum, control
510(k) Number K902484
Device Name BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
Original Applicant
BECKMAN INSTRUMENTS, INC.
200 south kraemer blvd., w-337
box 8000
brea,  CA  92622 -8000
Original Contact william t ryan
Regulation Number866.5550
Classification Product Code
DFH  
Date Received06/05/1990
Decision Date 06/21/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-