SeptiCyte LAB
FDA 510(k) clearance K163260 · decided 2017-02-17
Clearance details
- K-number
- K163260
- Device name
- SeptiCyte LAB
- Applicant
- Immunexpress, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-11-21
- Decision date
- 2017-02-17
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- PRE
- Device class
- 2
- Regulation number
- 866.3215
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TriVerity (K241676) | Inflammatix, Inc. | 2025-01-10 |
| SeptiCyte RAPID (K232095) | Immunexpress, Inc. | 2023-12-15 |
| SeptiCyte RAPID (K203748) | Immunexpress, Inc. | 2021-11-29 |
Recalls involving this device
No recalls on record reference this clearance.