K974678 is an FDA 510(k) clearance for the B-D AUTO-INJECTOR. This device is classified as a Introducer, Syringe Needle (Class II - Special Controls, product code KZH).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 29, 1998, 165 days after receiving the submission on December 15, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6920.
| 510(k) Number | K974678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 1997 |
| Decision Date | May 29, 1998 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KZH — Introducer, Syringe Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6920 |