Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)— 510(k) K231383
Substantially EquivalentTerragene S.A.
FDA 510(k) clearance K231383 for Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40), Substantially Equivalent on 2024-09-18. Applicant: Terragene S.A.. Device class: 2.
Clearance details
- 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
view allMore clearances from Terragene S.A.
view all- K242453 — Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2) +1 more
- DEN220042 — Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
- K232103 — Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
- K221641 — Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)
- K200272 — Terragene Chemdye
Data sourced from openFDA. This site is unofficial and independent of the FDA.