510(k) K232545
- Device
- The SensiTox B. anthracis Toxin Test
- Applicant
- First Light Diagnostics, Inc.
- 510(k) number
- K232545
- Product code
- QUU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-20
- Date received
- 2023-08-22
- Regulation
- 866.3046
- Classification name
- Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Joanne Spadoro
- Address
- 2 Omni Way Chelmsford MA US 01824 01824
FDA Registration Numbers#
- 3032562
Source Documents#
Other 510(k) Records For Product Code QUU#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN220044 | Active Anthrax DetectTM Plus Rapid Test | InBios International, Inc. | 2023-02-03 |