K243064 is an FDA 510(k) clearance for the ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold). This device is classified as a Test, Opiates, Over The Counter (Class II - Special Controls, product code NGL).
Submitted by Eterbio, Inc. (Zhuhai, CN). The FDA issued a Cleared decision on November 20, 2024, 54 days after receiving the submission on September 27, 2024.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K243064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2024 |
| Decision Date | November 20, 2024 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | NGL - Test, Opiates, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |