K150168 is an FDA 510(k) clearance for the Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL). This device is classified as a Enzyme Immunoassay, Tracrolimus (Class II - Special Controls, product code MLM).
Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on November 4, 2015, 282 days after receiving the submission on January 26, 2015.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1678.
| 510(k) Number | K150168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2015 |
| Decision Date | November 04, 2015 |
| Days to Decision | 282 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | MLM — Enzyme Immunoassay, Tracrolimus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1678 |