K970212 is an FDA 510(k) clearance for the LEVOFLOXACIN, 5MCG, SENSI-DISC. This device is classified as a Susceptibility Test Discs, Antimicrobial (Class II - Special Controls, product code JTN).
Submitted by Becton Dickinson Microbiology Systems (Cockeysville, US). The FDA issued a Cleared decision on March 6, 1997, 44 days after receiving the submission on January 21, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1620.
| 510(k) Number | K970212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 1997 |
| Decision Date | March 06, 1997 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JTN — Susceptibility Test Discs, Antimicrobial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1620 |