POCKETCHEM UA AUTION STICKS 10TA


Device Classification Name

method, enzymatic, glucose (urinary, non-quantitative)

510(k) Number K022386
Device Name POCKETCHEM UA AUTION STICKS 10TA
Original Applicant
ARKRAY, INC.
163 cabot st.
beverly, 
MA 
01915

Original Contact fran white
Regulation Number 862.1340
Classification Product Code
JIL  
Subsequent Product Codes
JIP   KQO  
Date Received 07/22/2002
Decision Date 09/17/2002
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