POINTCARE NOW SYSTEM


Device Classification Name

counter, differential cell

510(k) Number K072869
Device Name POINTCARE NOW SYSTEM
Applicant
POINTCARE TECHNOLOGIES INC.
181 cedar hill st.
marlborough, 
MA 
01752

Applicant Contact maurice n doire
Correspondent
POINTCARE TECHNOLOGIES INC.
181 cedar hill st.
marlborough, 
MA 
01752

Correspodent Contact maurice n doire
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 10/09/2007
Decision Date 01/14/2008
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

Recalls CDRH Recalls