K874646 is an FDA 510(k) clearance for the TDXR DELTA-9-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 December 18, 1987, 35 days after receiving the submission on November 13, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K874646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1987 |
| Decision Date | December 18, 1987 |
| Days to Decision | 35 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 |