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 K910473
Device Name CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC
Applicant
Coulter Immunology
440 Coulter Way
West 20th St.
Hialeah,  FL  33010
Applicant Contact GREGORY M BUTCHKO
Correspondent
Coulter Immunology
440 Coulter Way
West 20th St.
Hialeah,  FL  33010
Correspondent Contact GREGORY M BUTCHKO
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/04/1991
Decision Date 10/31/1991
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
-
-