K983309 is an FDA 510(k) clearance for the SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN. This device is classified as a Panels, Test, Susceptibility, Antimicrobial (Class II - Special Controls, product code LTT).
Submitted by Accumed Intl., Inc. (Westlake, US). The FDA issued a Cleared decision on December 14, 1998, 84 days after receiving the submission on September 21, 1998.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K983309 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 1998 |
| Decision Date | December 14, 1998 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LTT — Panels, Test, Susceptibility, Antimicrobial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |