K904569 is an FDA 510(k) clearance for the EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS. This device is classified as a Calibrators, Drug Specific (Class II - Special Controls, product code DLJ).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on December 26, 1990, 78 days after receiving the submission on October 9, 1990.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3200.
| 510(k) Number | K904569 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 1990 |
| Decision Date | December 26, 1990 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DLJ — Calibrators, Drug Specific |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3200 |