K202644 is an FDA 510(k) clearance for the Acetaminophen. This device is classified as a Colorimetry, Acetaminophen (Class II - Special Controls, product code LDP).
Submitted by Sekisui Diagnostics P.E.I., Inc. (Charlottetown, CA). The FDA issued a Cleared decision on February 18, 2022, 525 days after receiving the submission on September 11, 2020.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3030.
| 510(k) Number | K202644 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2020 |
| Decision Date | February 18, 2022 |
| Days to Decision | 525 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LDP - Colorimetry, Acetaminophen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3030 |