MAGNESIUM ASSAY


Device Classification Name

photometric method, magnesium

510(k) Number K111915
Device Name MAGNESIUM ASSAY
Applicant
SEKISUI DIAGNOSTICS P.E.I. INC.
70 watts avenue
charlottetown
prince edward island, 

CA

c1e2b9

Applicant Contact penny j white
Correspondent
SEKISUI DIAGNOSTICS P.E.I. INC.
70 watts avenue
charlottetown
prince edward island, 

CA

c1e2b9

Correspodent Contact penny j white
Regulation Number 862.1495
Classification Product Code
JGJ  
Date Received 07/06/2011
Decision Date 12/02/2011
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