• 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 flow cytometric reagents and accessories.
510(k) Number K121445
Device Name TETRACHROME REAGENTS AND TETRACXP SYSTEM
Original Applicant
BECKMAN COULTER, INC.
11800 sw 147th ave.
m/s 31-b06
miami,  FL  33196 -2500
Original Contact nancy nadler
Regulation Number864.5220
Classification Product Code
OYE  
Date Received05/15/2012
Decision Date 07/26/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-