Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K122307 |
Device Name |
DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
BIOCARE CORPORATION |
4F, NO.12, LANE 5, SEC. 2 |
NASHAN RD LUJIHU TOWNSHIP |
TAOYUAN COUNTY,
TW
33852
|
|
Applicant Contact |
SHUCHI CHANG |
Correspondent |
BIOCARE CORPORATION |
4F, NO.12, LANE 5, SEC. 2 |
NASHAN RD LUJIHU TOWNSHIP |
TAOYUAN COUNTY,
TW
33852
|
|
Correspondent Contact |
SHUCHI CHANG |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/01/2012 |
Decision Date | 04/05/2013 |
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
|
|
|