K844664 is an FDA 510(k) clearance for the THE I.V. BAG. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Kabivitrum, Inc. (Berkeley, US). The FDA issued a Cleared decision on May 6, 1985, 157 days after receiving the submission on November 30, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K844664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 1984 |
| Decision Date | May 06, 1985 |
| Days to Decision | 157 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 |