PRESTIGE 24I; BIOLIS 24I; MGC 240


Device Classification Name

hexokinase, glucose

510(k) Number K103531
Device Name PRESTIGE 24I; BIOLIS 24I; MGC 240
Applicant
TOKYO BOEKI MEDISYS INC.
5105 fairoaks road
durham, 
NC 
27712

Applicant Contact james m clinton
Correspondent
TOKYO BOEKI MEDISYS INC.
5105 fairoaks road
durham, 
NC 
27712

Correspodent Contact james m clinton
Regulation Number 862.1345
Classification Product Code
CFR  
Subsequent Product Code
JJE  
Date Received 12/01/2010
Decision Date 12/01/2011
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