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 Mixture, Hematology Quality Control
510(k) Number K930119
Device Name COULTER RETIC-C CELL CONTROL
Applicant
Coulter Electronics, Inc.
600 W. 20th St.
Hialeah,  FL  33010
Applicant Contact BENITA BRADFORD
Correspondent
Coulter Electronics, Inc.
600 W. 20th St.
Hialeah,  FL  33010
Correspondent Contact BENITA BRADFORD
Regulation Number864.8625
Classification Product Code
JPK  
Date Received01/12/1993
Decision Date 04/05/1993
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
-
-