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 Tubing, Fluid Delivery
510(k) Number K950508
Device Name SYSMEX SF-3000
Applicant
Sysmex Corp.
6699 Rfd
Long Grove,  IL  60047
Applicant Contact NINA GAMPERLING
Correspondent
Sysmex Corp.
6699 Rfd
Long Grove,  IL  60047
Correspondent Contact NINA GAMPERLING
Regulation Number880.5440
Classification Product Code
FPK  
Date Received02/06/1995
Decision Date 11/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-