K083262 is an FDA 510(k) clearance for the MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML). This device is classified as a Panels, Test, Susceptibility, Antimicrobial (Class II - Special Controls, product code LTT).
Submitted by Siemens Healthcare Diagnostics (West Sacramento, US). The FDA issued a Cleared decision on February 18, 2009, 105 days after receiving the submission on November 5, 2008.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K083262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2008 |
| Decision Date | February 18, 2009 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LTT — Panels, Test, Susceptibility, Antimicrobial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |