Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K102383 |
Device Name |
MICRODOT & MICRODOT XTRA |
Applicant |
CAMBRIDGE SENSORS LIMITED |
UNITS 9&10 CARDINAL PARK |
GODMANCHESTER |
HUNTINGDON, CAMBRIDGESHIRE,
GB
PE29 2XG
|
|
Applicant Contact |
BERNADETTE YON-HIN |
Correspondent |
CAMBRIDGE SENSORS LIMITED |
UNITS 9&10 CARDINAL PARK |
GODMANCHESTER |
HUNTINGDON, CAMBRIDGESHIRE,
GB
PE29 2XG
|
|
Correspondent Contact |
BERNADETTE YON-HIN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/23/2010 |
Decision Date | 01/27/2012 |
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
|
|
|