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, Primary
510(k) Number K000331
Device Name SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd.,M/S W-104
Box 8000
Brea,  CA  92822 -8000
Applicant Contact GAIL LEFEBVRE
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd.,M/S W-104
Box 8000
Brea,  CA  92822 -8000
Correspondent Contact GAIL LEFEBVRE
Regulation Number862.1150
Classification Product Code
JIS  
Date Received12/22/1999
Decision Date 02/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-