K013757 is an FDA 510(k) clearance for the ROCHE ACETAMINOPHEN. This device is classified as a Colorimetry, Acetaminophen (Class II - Special Controls, product code LDP).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 8, 2002, 56 days after receiving the submission on November 13, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3030.
| 510(k) Number | K013757 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2001 |
| Decision Date | January 08, 2002 |
| Days to Decision | 56 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 |