K790400 is an FDA 510(k) clearance for the URINE NEGATIVE CALIBRATOR. This device is classified as a Hemagglutination, Opiates (Class II - Special Controls, product code DLT).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1979, 109 days after receiving the submission on February 26, 1979.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K790400 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 1979 |
| Decision Date | June 15, 1979 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DLT — Hemagglutination, Opiates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |