The following data is part of a premarket notification filed by Abbott Point Of Care, Inc. with the FDA for I-stat Alinity System With I-stat Glucose Test.
| Device ID | K163271 |
| 510k Number | K163271 |
| Device Name: | I-Stat Alinity System With I-Stat Glucose Test |
| Classification | Glucose Oxidase, Glucose |
| Applicant | Abbott Point Of Care, Inc. 400 College Road East Princeton, NJ 08540 |
| Contact | Maria L Figueroa |
| Correspondent | Maria L Figueroa Abbott Point Of Care, Inc. 400 College Road East Princeton, NJ 08540 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-21 |
| Decision Date | 2017-04-10 |
| Summary: | summary |