K821379 is an FDA 510(k) clearance for the EMIT-TOX ACETAMINOPHEN ASSAY. This device is classified as a Colorimetry, Acetaminophen (Class II - Special Controls, product code LDP).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982, 18 days after receiving the submission on May 10, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3030.
| 510(k) Number | K821379 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 1982 |
| Decision Date | May 28, 1982 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LDP — Colorimetry, Acetaminophen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3030 |