The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Levofloxacin, 5mcg, Sensi-disc.
| Device ID | K970212 |
| 510k Number | K970212 |
| Device Name: | LEVOFLOXACIN, 5MCG, SENSI-DISC |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Contact | Virginia C Weinknecht |
| Correspondent | Virginia C Weinknecht 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 | 1997-01-21 |
| Decision Date | 1997-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382902317050 | K970212 | 000 |
| 30382902317068 | K970212 | 000 |