MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K103364
Device Name MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL
Applicant
DIAMOND DIAGNOSTICS, INC
333 fiske st
holliston, 
MA 
01746

Applicant Contact liann voo
Correspondent
DIAMOND DIAGNOSTICS, INC
333 fiske st
holliston, 
MA 
01746

Correspodent Contact liann voo
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 11/16/2010
Decision Date 05/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No