K821767 is an FDA 510(k) clearance for the EMIT ST URINE METHAGUALONE CALIBRATOR. This device is classified as a Calibrators, Drug Mixture (Class II - Special Controls, product code DKB).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1982, 10 days after receiving the submission on June 15, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3200.
| 510(k) Number | K821767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1982 |
| Decision Date | June 25, 1982 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DKB — Calibrators, Drug Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3200 |