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 K032677
Device Name SYSMEX POCH-100I
Applicant
Sysmex America, Inc.
One Nelson C. White Pkwy.
Mundelein,  IL  60060
Applicant Contact CHRIS STUKEL
Correspondent
Sysmex America, Inc.
One Nelson C. White Pkwy.
Mundelein,  IL  60060
Correspondent Contact CHRIS STUKEL
Regulation Number864.5200
Classification Product Code
GKL  
Subsequent Product Code
GKZ  
Date Received08/29/2003
Decision Date 02/11/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-