K070820 is an FDA 510(k) clearance for the ARCHITECT TACROLIMUS: MODEL 1L77. This device is classified as a Enzyme Immunoassay, Tracrolimus (Class II - Special Controls, product code MLM).
Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on August 1, 2007, 128 days after receiving the submission on March 26, 2007.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1678.
| 510(k) Number | K070820 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2007 |
| Decision Date | August 01, 2007 |
| Days to Decision | 128 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 |