Device Classification Name |
Glucose Dehydrogenase, Glucose
|
510(k) Number |
K110637 |
Device Name |
ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
CILAG GMBH INTERNATIONAL |
LANDIS AND GYR STRASSE 1 |
ZUG,
CH
6300
|
|
Applicant Contact |
FIONA LEEPER |
Correspondent |
CILAG GMBH INTERNATIONAL |
LANDIS AND GYR STRASSE 1 |
ZUG,
CH
6300
|
|
Correspondent Contact |
FIONA LEEPER |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/04/2011 |
Decision Date | 09/07/2011 |
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
|
Recalls |
CDRH Recalls
|
|
|