K210818 is an FDA 510(k) clearance for the TrueCare Biomedix Tamper Evident Cap. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Us Infusion Inc. D/B/A Truecare Biomedix-USA (South Miami, US). The FDA issued a Cleared decision on September 15, 2021, 181 days after receiving the submission on March 18, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K210818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2021 |
| Decision Date | September 15, 2021 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |