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 K864579
Device Name MINOS AUTOMATIC CELL COUNTER
Applicant
Abx, Inc.
R.D. #3 Box 416
Ringoes,  NJ  08551
Applicant Contact RANDOLPH L COOKE
Correspondent
Abx, Inc.
R.D. #3 Box 416
Ringoes,  NJ  08551
Correspondent Contact RANDOLPH L COOKE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received11/20/1986
Decision Date 07/16/1987
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
-
-