K844167 is an FDA 510(k) clearance for the ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT. This device is classified as a Radioimmunoassay, Phenobarbital (Class II - Special Controls, product code DKP).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on November 27, 1984, 33 days after receiving the submission on October 25, 1984.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3660.
| 510(k) Number | K844167 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1984 |
| Decision Date | November 27, 1984 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DKP — Radioimmunoassay, Phenobarbital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3660 |