K151203 is an FDA 510(k) clearance for the Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).
Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on June 5, 2015, 31 days after receiving the submission on May 5, 2015.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K151203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2015 |
| Decision Date | June 05, 2015 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |