HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004


Device Classification Name

mixture, hematology quality control

510(k) Number K073178
Device Name HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
Applicant
R & D SYSTEMS, INC.
614 mckinley pl., n.e.
minneapolis, 
MN 
55413

Applicant Contact nancy c ring
Correspondent
R & D SYSTEMS, INC.
614 mckinley pl., n.e.
minneapolis, 
MN 
55413

Correspodent Contact nancy c ring
Regulation Number 864.8625
Classification Product Code
JPK  
Date Received 11/13/2007
Decision Date 12/27/2007
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