K142518 is an FDA 510(k) clearance for the HumaPen Luxura. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Eli Lilly and Company (Indianapolis, US). The FDA issued a Cleared decision on June 5, 2015, 270 days after receiving the submission on September 8, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K142518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2014 |
| Decision Date | June 05, 2015 |
| Days to Decision | 270 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 |