The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for I-stat Tbi Plasma Cartridge With The I-stat Alinity System.
| Device ID | K201778 |
| 510k Number | K201778 |
| Device Name: | I-STAT TBI Plasma Cartridge With The I-STAT Alinity System |
| Classification | Brain Trauma Assessment Test |
| Applicant | Abbott Laboratories 400 College Road East Princeton, NJ 08540 |
| Contact | Brian Ma |
| Correspondent | Brian Ma Abbott Laboratories 400 College Road East Princeton, NJ 08540 |
| Product Code | QAT |
| CFR Regulation Number | 866.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-30 |
| Decision Date | 2021-01-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00054749005062 | K201778 | 000 |
| 00054749005611 | K201778 | 000 |