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 alkaline picrate, colorimetry, creatinine
510(k) Number K071277
Device Name SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD.
M/S W-110
BREA,  CA  92822 -8000
Applicant Contact TARA M VIVIANI
Correspondent
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD.
M/S W-110
BREA,  CA  92822 -8000
Correspondent Contact TARA M VIVIANI
Regulation Number862.1225
Classification Product Code
CGX  
Subsequent Product Code
JIX  
Date Received05/07/2007
Decision Date 06/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-