K011300 is an FDA 510(k) clearance for the EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).
Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on May 17, 2001, 17 days after receiving the submission on April 30, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K011300 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2001 |
| Decision Date | May 17, 2001 |
| Days to Decision | 17 days |
| Submission Type | Special |
| 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 |