Submission Details
| 510(k) Number | K223023 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 2022 |
| Decision Date | May 09, 2023 |
| Days to Decision | 222 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
May 2023
Decision
222d
Days
Class 2
Risk
About This 510(k) Submission
K223023 is an FDA 510(k) clearance for the Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40), a Indicator, Biological Sterilization Process (Class II — Special Controls, product code FRC), submitted by Plasmapp Co,., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on May 9, 2023, 222 days after receiving the submission on September 29, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.
Device Classification
| Product Code | FRC — Indicator, Biological Sterilization Process |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.2800 |
Manufacturer
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