K844077 is an FDA 510(k) clearance for the NUTRIMIX EMPTY CONTAINER. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 15, 1985, 119 days after receiving the submission on October 19, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K844077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1984 |
| Decision Date | February 15, 1985 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KPE — Container, I.v. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5025 |