MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K021930
Device Name MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL
Original Applicant
BIONOSTICS, INC.
7 jackson rd.
devens, 
MA 
01432

Original Contact kathy storro
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 06/12/2002
Decision Date 06/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No