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 K850171
Device Name SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS
Applicant
Toa Medical Electronics USA, Inc.
1515 E Del Amo Blvd.
Carson,  CA  90746
Applicant Contact RICHARD CARSTENS
Correspondent
Toa Medical Electronics USA, Inc.
1515 E Del Amo Blvd.
Carson,  CA  90746
Correspondent Contact RICHARD CARSTENS
Regulation Number864.5200
Classification Product Code
GKL  
Date Received01/16/1985
Decision Date 05/13/1985
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
-
-