510(k) DEN220044
- Device
- Active Anthrax DetectTM Plus Rapid Test
- Applicant
- InBios International, Inc.
- 510(k) number
- DEN220044
- Product code
- QUU
- Decision
- Unknown (DENG)
- Decision date
- 2023-02-03
- Date received
- 2022-07-08
- 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
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Estela Raychaudhuri
- Address
- 307 Westlake Ave. N, Suite 300 Seattle WA US 98109 98109
FDA Registration Numbers#
- 3032562
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QUU#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232545 | The SensiTox B. anthracis Toxin Test | First Light Diagnostics, Inc. | 2023-11-20 |