The SensiTox B. anthracis Toxin Test
FDA 510(k) clearance K232545 · decided 2023-11-20
Clearance details
- K-number
- K232545
- Device name
- The SensiTox B. anthracis Toxin Test
- Applicant
- First Light Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-08-22
- Decision date
- 2023-11-20
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- QUU
- Device class
- 2
- Regulation number
- 866.3046
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Chelmsford, MA, 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 |
|---|---|---|
| Active Anthrax DetectTM Plus Rapid Test (DEN220044) | InBios International, Inc. | 2023-02-03 |
Recalls involving this device
No recalls on record reference this clearance.