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 Counter, Cell, Automated (Particle Counter)
510(k) Number K840170
Device Name CELL-DYN 100 WHOLE BLOOD PLATELET
Applicant
Abbott Diagnostics
850 Maude Ave.
Mountain View,  CA  94043
Correspondent
Abbott Diagnostics
850 Maude Ave.
Mountain View,  CA  94043
Regulation Number864.5200
Classification Product Code
GKL  
Date Received01/19/1984
Decision Date 03/02/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-