Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
FDA 510(k) clearance DEN220042 · decided 2024-07-12
Clearance details
- K-number
- DEN220042
- Device name
- Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
- Applicant
- Terragene S.A.
- Decision
- Unknown
- Date received
- 2022-07-01
- Decision date
- 2024-07-12
- Days to decision
- 742 days
- Clearance type
- Direct
- Product code
- QVB
- Device class
- 2
- Regulation number
- 880.2806
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Alvear, AR
- 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 |
|---|---|---|
| InstaTRU Instant Biological Indicator for Steam (IBI-05) (K251559) | True Indicating, LLC | 2026-06-18 |
| 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) (K252306) | Steritec Products | 2026-04-22 |
Recalls involving this device
No recalls on record reference this clearance.