K854044 is an FDA 510(k) clearance for the TDX BARBITURATES. This device is classified as a Fluorescence Polarization Immunoassay, Phenobarbital (Class II - Special Controls, product code LGQ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 28, 1985, 26 days after receiving the submission on October 2, 1985.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3660.
| 510(k) Number | K854044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 1985 |
| Decision Date | October 28, 1985 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LGQ — Fluorescence Polarization Immunoassay, Phenobarbital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3660 |