GENSTRIP TEST STRIP MODEL 100-201


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K103542
Device Name GENSTRIP TEST STRIP MODEL 100-201
Applicant
SHASTA TECHNOLOGIES, LLC
611 w 5th st.
3rd floor
austin, 
TX 
78701

Applicant Contact caroline tontini
Correspondent
SHASTA TECHNOLOGIES, LLC
611 w 5th st.
3rd floor
austin, 
TX 
78701

Correspodent Contact caroline tontini
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received 12/02/2010
Decision Date 11/30/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No