The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Gemifloxacin, 5ug Bbl Sensi-disc.
| Device ID | K050062 |
| 510k Number | K050062 |
| Device Name: | GEMIFLOXACIN, 5UG BBL SENSI-DISC |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | BECTON DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 |
| Contact | Bradford Spring |
| Correspondent | Bradford Spring BECTON DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-11 |
| Decision Date | 2005-02-10 |
| Summary: | summary |