INRATIO SELF-TEST


Device Classification Name

test, time, prothrombin

510(k) Number K021923
Device Name INRATIO SELF-TEST
Original Applicant
HEMOSENSE, INC.
600 valley way
milpitas, 
CA 
95035

Original Contact judith blunt
Regulation Number 864.7750
Classification Product Code
GJS  
Date Received 06/11/2002
Decision Date 10/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls