Device Classification Name |
Electrode, Ion Specific, Calcium
|
510(k) Number |
K191360 |
Device Name |
i-STAT CHEM8+ cartridge with the i-STAT 1 System |
Applicant |
Abbott Point of Care, Inc. |
400 College Road East |
Princeton,
NJ
08540
|
|
Applicant Contact |
Susan Tibedo |
Correspondent |
Abbott Point of Care, Inc. |
400 College Road East |
Princeton,
NJ
08540
|
|
Correspondent Contact |
Susan Tibedo |
Regulation Number | 862.1145
|
Classification Product Code |
|
Date Received | 05/21/2019 |
Decision Date | 02/14/2020 |
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
|
|
|