Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye— 510(k) K191021
Substantially EquivalentTerragene S.A.
FDA 510(k) clearance K191021 for Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye, Substantially Equivalent on 2019-09-13. 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
- K231383 — 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)
- 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)
Recalls naming K191021
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191021.
Data sourced from openFDA. This site is unofficial and independent of the FDA.