The following data is part of a premarket notification filed by Abbott Point Of Care Inc. with the FDA for I-stat Chem8+ Cartridge With The I-stat 1 System.
| Device ID | K210958 |
| 510k Number | K210958 |
| Device Name: | I-STAT CHEM8+ Cartridge With The I-STAT 1 System |
| Classification | Glucose Oxidase, Glucose |
| Applicant | Abbott Point Of Care Inc. 400 College Road East Princeton, NJ 08540 |
| Contact | Maria Figueroa |
| Correspondent | Maria Figueroa Abbott Point Of Care Inc. 400 College Road East Princeton, NJ 08540 |
| Product Code | CGA |
| Subsequent Product Code | CDS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGL |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JFL |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JPI |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-31 |
| Decision Date | 2021-08-13 |