K840941 is an FDA 510(k) clearance for the TDX ACETAMINOPHEN. This device is classified as a Colorimetry, Acetaminophen (Class II - Special Controls, product code LDP).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 11, 1984, 67 days after receiving the submission on March 5, 1984.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3030.
| 510(k) Number | K840941 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 1984 |
| Decision Date | May 11, 1984 |
| Days to Decision | 67 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 |