IDEAL LIFE POD (MODEL ILP 0001)


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K080538
Device Name IDEAL LIFE POD (MODEL ILP 0001)
Applicant
IDEAL LIFE INC.
2995 steven martin dr
fairfax, 
VA 
22031

Applicant Contact diane horwitz
Correspondent
IDEAL LIFE INC.
2995 steven martin dr
fairfax, 
VA 
22031

Correspodent Contact diane horwitz
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received 02/26/2008
Decision Date 07/03/2008
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