• 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 apolipoproteins
510(k) Number K970314
Device Name SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
Original Applicant
BECKMAN INSTRUMENTS, INC.
200 south kraemer blvd., w-337
box 8000
brea,  CA  92622 -8000
Original Contact kathleen m jaker
Regulation Number862.1475
Classification Product Code
MSJ  
Subsequent Product Code
JIT  
Date Received01/24/1997
Decision Date 04/21/1997
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-