K910213 is an FDA 510(k) clearance for the NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION. 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 April 16, 1991, 96 days after receiving the submission on January 10, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K910213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 1991 |
| Decision Date | April 16, 1991 |
| Days to Decision | 96 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 |