Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)— 510(k) K221641
Substantially EquivalentTerragene S.A.
FDA 510(k) clearance K221641 for Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB), Substantially Equivalent on 2023-02-28. Applicant: Terragene S.A..
Clearance details
- Applicant
- Terragene S.A.
- Product code
- Code FRC
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alvear, AR
Data sourced from openFDA. This site is unofficial and independent of the FDA.