K010623 is an FDA 510(k) clearance for the RECONSTITUTION KIT & VIAL CONNECTOR. This device is classified as a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI).
Submitted by Bioject, Inc. (Portland, US). The FDA issued a Cleared decision on April 5, 2001, 34 days after receiving the submission on March 2, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K010623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2001 |
| Decision Date | April 05, 2001 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI — Set, I.v. Fluid Transfer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5440 |