The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Amdinocillin 10 Mcg Sensi-disc.
| Device ID | K850357 |
| 510k Number | K850357 |
| Device Name: | AMDINOCILLIN 10 MCG SENSI-DISC |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Contact | Russell J Arnsberge |
| Correspondent | Russell J Arnsberge BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-30 |
| Decision Date | 1985-03-20 |