K864751 is an FDA 510(k) clearance for the TDXR CANNABINOIDS. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 13, 1987, 98 days after receiving the submission on December 5, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K864751 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 1986 |
| Decision Date | March 13, 1987 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |