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 Apparatus, Automated Blood Cell Diluting
510(k) Number K882767
Device Name SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM
Applicant
Toa Medical Electronics USA, Inc.
4410 Cerritos Ave.
Los Alamitos,  CA  90720
Applicant Contact PAUL N BRODEN
Correspondent
Toa Medical Electronics USA, Inc.
4410 Cerritos Ave.
Los Alamitos,  CA  90720
Correspondent Contact PAUL N BRODEN
Regulation Number864.5240
Classification Product Code
GKH  
Date Received07/06/1988
Decision Date 07/18/1988
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
-
-