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 Control, Cell Counter, Normal And Abnormal
510(k) Number K934497
Device Name CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE
Applicant
R&D Systems, Inc.
614 Mckinley Pl. NE
Minneapolis,  MN  55413
Applicant Contact KAREN VISKOCHIL
Correspondent
R&D Systems, Inc.
614 Mckinley Pl. NE
Minneapolis,  MN  55413
Correspondent Contact KAREN VISKOCHIL
Regulation Number864.8625
Classification Product Code
JCN  
Subsequent Product Code
JPK  
Date Received09/14/1993
Decision Date 12/06/1993
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
-
-