GLUCOLEADER VALUE


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K023279
Device Name GLUCOLEADER VALUE
Original Applicant
HMD BIOMEDICAL, INC.
3505 sunset ave.
ocean, 
NJ 
07712

Original Contact jeffrey fleishman
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received 10/01/2002
Decision Date 08/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No