Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2) +1 more— 510(k) K242453
Substantially EquivalentTerragene S.A.
FDA 510(k) clearance K242453 for Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2) +1 more, Substantially Equivalent on 2024-12-12. Applicant: Terragene S.A.. Device class: 2.
Clearance details
- Device name as filed
- Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)
- Applicant
- Terragene S.A.
- Product code
- Code FRC
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alvear, AR
Recent devices under product code FRC
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- K221641 — Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)
- K200272 — Terragene Chemdye
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