K904541 is an FDA 510(k) clearance for the LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS. 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 November 20, 1990, 47 days after receiving the submission on October 4, 1990.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K904541 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1990 |
| Decision Date | November 20, 1990 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |