K844962 is an FDA 510(k) clearance for the EMIT QST ACETAMINOPHEN ASSAY. This device is classified as a Colorimetry, Acetaminophen (Class II - Special Controls, product code LDP).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on January 18, 1985, 25 days after receiving the submission on December 24, 1984.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3030.
| 510(k) Number | K844962 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 1984 |
| Decision Date | January 18, 1985 |
| Days to Decision | 25 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 |