The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Cetibuten, 30mcg, Sensi-disc.
| Device ID | K965159 |
| 510k Number | K965159 |
| Device Name: | CETIBUTEN, 30MCG, SENSI-DISC |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Contact | Robert E James |
| Correspondent | Robert E James BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-23 |
| Decision Date | 1997-02-04 |
| Summary: | summary |