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 Calibrator, Multi-Analyte Mixture
510(k) Number K110251
Device Name SYNCHRON MULTI CALIBRATOR
Applicant
BECKMAN COULTER, INC.
250 S. KRAEMER BOULEVARD
MAIL STOP E2 SE08
BREA,  CA  92821
Applicant Contact Yvette Lloyd
Correspondent
BECKMAN COULTER, INC.
250 S. KRAEMER BOULEVARD
MAIL STOP E2 SE08
BREA,  CA  92821
Correspondent Contact Yvette Lloyd
Regulation Number862.1150
Classification Product Code
JIX  
Date Received01/28/2011
Decision Date 05/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-