K963012 is an FDA 510(k) clearance for the BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM). 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 October 15, 1996, 74 days after receiving the submission on August 2, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K963012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 1996 |
| Decision Date | October 15, 1996 |
| Days to Decision | 74 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 |