The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Grepafloxacin, 5 Mg, Sensi-disc.
| Device ID | K974578 |
| 510k Number | K974578 |
| Device Name: | GREPAFLOXACIN, 5 MG, SENSI-DISC |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Virginia C Weinknecht |
| Correspondent | Virginia C Weinknecht BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-08 |
| Decision Date | 1998-02-23 |
| Summary: | summary |