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, Differential Cell
510(k) Number K983562
Device Name MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700
Applicant
CDC TECHNOLOGIES, INC.
1250 24TH STREET, N.W. 7TH FL
WASHINGTON,  DC  20037
Applicant Contact GEORGE J WALLACE
Correspondent
CDC TECHNOLOGIES, INC.
1250 24TH STREET, N.W. 7TH FL
WASHINGTON,  DC  20037
Correspondent Contact GEORGE J WALLACE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received10/13/1998
Decision Date 11/03/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-