BIOLIS 12I


Device Classification Name

electrode, ion specific, potassium

510(k) Number K110520
Device Name BIOLIS 12I
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 862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CFR   CGZ   JGS   JJE  
Date Received 02/23/2011
Decision Date 03/23/2012
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