Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K151639 |
Device Name |
ABL80 FLEX and ABL80 FLEX CO-OX |
Applicant |
SENDX MEDICAL INC |
1945 PALOMAR OAKS WAY |
CARLSBAD,
CA
92011
|
|
Applicant Contact |
VIBEKE AGERLIN |
Correspondent |
RADIOMETER MEDICAL APS |
AKANDEVEJ 21 |
BRONSHOJ,
DK
2700
|
|
Correspondent Contact |
SOREN BOGESTRAND |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 06/18/2015 |
Decision Date | 12/07/2015 |
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
|
|
|