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Terragene Bionova Photon Biological Indicator - Terragene Bionova Photon Auto-Reader Incubator (BPH)
FDA 510(k)Class II (US FDA 510(k))
510(k) DEN220042
Identifiers
- 510(k) Number
- DEN220042 FDA 510(k)
- FDA Product Code
- QVB FDA 510(k)
- Models / Variants
- Terragene Bionova Photon Auto-Reader Incubator (BPH) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2806 FDA 510(k)
- Regulation Number
- 880.2806 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
Terragene Bionova Photon Biological Indicator - Terragene Bionova Photon Auto-Reader Incubator (BPH) by Terragene S.a. — Class II — FDA_510K — listed in FDA…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN220042 | Class II | Active |
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Manufacturer
- Manufacturer
- Terragene S.a.
Sources (1)
- FDA 510(k) DEN220042 24 fields · synced Jun 18, 2026