K953094 is an FDA 510(k) clearance for the AXSYM 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 August 24, 1995, 52 days after receiving the submission on July 3, 1995.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3030.
| 510(k) Number | K953094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 1995 |
| Decision Date | August 24, 1995 |
| Days to Decision | 52 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 |