Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K023279 |
Device Name |
GLUCOLEADER VALUE |
Applicant |
HMD BIOMEDICAL, INC. |
3505 SUNSET AVE. |
OCEAN,
NJ
07712
|
|
Applicant Contact |
JEFFREY FLEISHMAN |
Correspondent |
HMD BIOMEDICAL, INC. |
3505 SUNSET AVE. |
OCEAN,
NJ
07712
|
|
Correspondent Contact |
JEFFREY FLEISHMAN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
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
|
|
|