510(k) K252306
- Device
- 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)
- Applicant
- Steritec Products
- 510(k) number
- K252306
- Product code
- QVB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-22
- Date received
- 2025-07-24
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Darshan Yeliyur Siddegowda
- Address
- 74 Inverness Dr. E. Engelwood CO US 80112 80112
FDA Registration Numbers#
- 3015392401
- 3013145340
Source Documents#
Other 510(k) Records For Product Code QVB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN220042 | Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) | Terragene S.A. | 2024-07-12 |