MCT-DIABETES


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K073699
Device Name MCT-DIABETES
Applicant
MYCARE TEAM, INC.
po box 2552
fairfax, 
VA 
22031

Applicant Contact diane mandell horwitz
Correspondent
MYCARE TEAM, INC.
po box 2552
fairfax, 
VA 
22031

Correspodent Contact diane mandell horwitz
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received 12/31/2007
Decision Date 03/26/2008
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