MEDICA EASYQC HEMATOCRIT CONTROL


Device Classification Name

control, hematocrit

510(k) Number K021924
Device Name MEDICA EASYQC HEMATOCRIT CONTROL
Original Applicant
BIONOSTICS, INC.
7 jackson rd.
devens, 
MA 
01432

Original Contact kathy storro
Regulation Number 864.8625
Classification Product Code
GLK  
Date Received 06/11/2002
Decision Date 06/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No