K230035 is an FDA 510(k) clearance for the BioSci? Disposable Virus Sampling Tubes. This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).
Submitted by Shenzhen Dakewe Bio-Engineering Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 5, 2023, 90 days after receiving the submission on January 5, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K230035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2023 |
| Decision Date | April 05, 2023 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JSM — Culture Media, Non-propagating Transport |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2390 |