K091617 is an FDA 510(k) clearance for the QMS LIDOCAINE CALIBRATORS, MODEL 0374678. This device is classified as a Calibrators, Drug Specific (Class II - Special Controls, product code DLJ).
Submitted by Thermo Fisher Scientific (Indianapolis, US). The FDA issued a Cleared decision on July 17, 2009, 44 days after receiving the submission on June 3, 2009.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3200.
| 510(k) Number | K091617 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2009 |
| Decision Date | July 17, 2009 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DLJ — Calibrators, Drug Specific |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3200 |