Device Classification Name |
Electrode, Ion Specific, Potassium
|
510(k) Number |
K092849 |
Device Name |
BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER |
Applicant |
EPOCAL, INC. |
2060 WALKLEY RD. |
OTTAWA, ONTARIO,
CA
K1G-3P5
|
|
Applicant Contact |
ROY LAYER |
Correspondent |
EPOCAL, INC. |
2060 WALKLEY RD. |
OTTAWA, ONTARIO,
CA
K1G-3P5
|
|
Correspondent Contact |
ROY LAYER |
Regulation Number | 862.1600
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/16/2009 |
Decision Date | 03/30/2010 |
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
|
|
|