510(k) K201778
- Device
- I-STAT TBI Plasma Cartridge With The I-STAT Alinity System
- Applicant
- Abbott Laboratories
- 510(k) number
- K201778
- Product code
- QAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-01-08
- Date received
- 2020-06-30
- Regulation
- 866.5830
- Classification name
- Brain Trauma Assessment Test
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Brian Ma
- Address
- 400 College Rd. E. Princton NJ US 08540 08540
FDA Registration Numbers#
- 3005643513
- 8020790
- 2245578
- 3008344661
- 3002809144
- 2085064
- 2953756
- 3005333358
- 2032839
Source Documents#
Other 510(k) Records For Product Code QAT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240279 | VIDAS TBI (GFAP, UCH-L1) | bioMerieux, Inc. | 2024-05-01 |
| K234143 | i-STAT TBI Cartridge with the i-STAT Alinity System | Abbott Point of Care | 2024-03-27 |
| K232669 | TBI | Abbott Laboratories | 2023-09-29 |
| K223602 | Traumatic brain injury (TBI) test | Abbott Laboratories | 2023-03-02 |
| DEN170045 | Banyan BTI | Banyan Biomarkers, Inc. | 2018-02-14 |
Legacy Summary#
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FDA Review#
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