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 K945678
Device Name DATACELL 18MS
Applicant
Danam Electronics
4230 Shilling Way
Dallas,  TX  75237
Applicant Contact JERRY WEST
Correspondent
Danam Electronics
4230 Shilling Way
Dallas,  TX  75237
Correspondent Contact JERRY WEST
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received11/18/1994
Decision Date 09/12/1995
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
-
-