510(k) DEN220042
- Device
- Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
- Applicant
- Terragene S.A.
- 510(k) number
- DEN220042
- Product code
- QVB
- Decision
- Unknown (DENG)
- Decision date
- 2024-07-12
- Date received
- 2022-07-01
- Regulation
- 880.2806
- Classification name
- Biological Sterilization Indicator With Indirect Growth Detection
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Catalano Maximiliano
- Address
- Ruta Nacional # 9, Km 280, Parque Industrial Micropi Alvear AR 2130 2130
FDA Registration Numbers#
- 3015392401
- 3013145340
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QVB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252306 | Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100) | Steritec Products | 2026-04-22 |