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 | K183680 |
| 510k Number | K183680 |
| Device Name: | I-STAT CHEM8+ Cartridge With The I-STAT 1 System |
| Classification | Device, Hematocrit Measuring |
| Applicant | Abbott Point Of Care Inc. 400 College Road East Princeton, NJ 08540 |
| Contact | Susan Tibedo |
| Correspondent | Susan Tibedo Abbott Point Of Care Inc. 400 College Road East Princeton, NJ 08540 |
| Product Code | JPI |
| CFR Regulation Number | 864.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-28 |
| Decision Date | 2020-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00054749005512 | K183680 | 000 |