Device Classification Name |
electrode measurement, blood-gases (pco2, po2) and blood ph
|
510(k) Number |
K230285 |
Device Name |
i-STAT CG8+ cartridge with the i-STAT 1 System |
Applicant |
Abbott Point of Care Inc |
400 College Road East |
Princeton,
NJ
08540
|
|
Applicant Contact |
Jacquelyn Gesumaria |
Correspondent |
Abbott Point of Care Inc |
400 College Road East |
Princeton,
NJ
08540
|
|
Correspondent Contact |
Jacquelyn Gesumaria |
Regulation Number | 862.1120
|
Classification Product Code |
|
Date Received | 02/02/2023 |
Decision Date | 10/27/2023 |
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
|
|
|