Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
FDA 510(k) K223023 · Plasmapp Co,., Ltd.
510(k) numberK223023
Submission
- Device name
- Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
- Applicant
- Plasmapp Co,., Ltd.
Daejeon, KR - Received
- September 29, 2022
- Decision date
- May 9, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRC – Indicator, Biological Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
Other 510(k)s with product code FRC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260766 | Celerity 5 HP Biological Indicator (LCB052)FRC · Special | STERIS Corporation | 04/08/2026SE |
| K252680 | Celerity 20 HP Biological IndicatorFRC · Special | STERIS Corporation | 09/24/2025SE |
| K251122 | Terragene® Bionova® BT20 Biological IndicatorFRC · Traditional | Terragene | 08/04/2025SE |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | Steris | 06/06/2025SE |
| K250061 | Celerity IncubatorFRC · Special | STERIS Corporation | 02/06/2025SE |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | STERIS Corporation | 02/06/2025SE |
| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional | 3M Company | 01/28/2025SE |
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…FRC · Traditional | Terragene S.A. | 12/12/2024SE |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 3M Company | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 3M Company | 10/18/2024SE |
More from 3M Company
| 510(k) | Device | Decision |
|---|---|---|
| K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK…MLR · Special | 05/25/2023SE |
| K223025 | Tyvek Roll with CI for STERLINK SterilizerFRG · Traditional | 05/09/2023SE |
| K223015 | STERLINK FPS-15s Plus sterilizer with STERPACK plus cassetteMLR · Traditional | 05/09/2023SE |
| K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK…MLR · Traditional | 04/14/2023SE |
| K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM CassetteMLR · Traditional | 10/22/2021SE |
| K212198 | Tyvek(R) Roll with CI for STERLINKTM SterilizerFRG · Traditional | 10/22/2021SE |
| K212193 | Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD…FRC · Traditional | 10/22/2021SE |
Questions and answers
When was Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) cleared by the FDA?
Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (K223023) received a 510(k) decision of Substantially Equivalent on May 9, 2023, 222 days after the submission was received.
What is the product code of K223023?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.