K921365 is an FDA 510(k) clearance for the NUTRIMIX MICROCOMPOUNDER. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 30, 1992, 102 days after receiving the submission on March 20, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K921365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1992 |
| Decision Date | June 30, 1992 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LHI — Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |