Device Classification Name |
Glucose Oxidase, Glucose
|
510(k) Number |
K983504 |
Device Name |
PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST |
Applicant |
MEDISENSE, INC. |
4-A CROSBY DR. |
BEDFORD,
MA
01730 -1402
|
|
Applicant Contact |
MICHAEL HALPIN |
Correspondent |
MEDISENSE, INC. |
4-A CROSBY DR. |
BEDFORD,
MA
01730 -1402
|
|
Correspondent Contact |
MICHAEL HALPIN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 10/06/1998 |
Decision Date | 07/09/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|