K901404 is an FDA 510(k) clearance for the NUTRIMIX MACRO TPN COMPOUNDER. 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 26, 1990, 92 days after receiving the submission on March 26, 1990.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K901404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1990 |
| Decision Date | June 26, 1990 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LHI — Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |