K844171 is an FDA 510(k) clearance for the PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE. This device is classified as a Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) (Class II - Special Controls, product code LGR).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on December 10, 1984, 46 days after receiving the submission on October 25, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3350.
| 510(k) Number | K844171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1984 |
| Decision Date | December 10, 1984 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LGR — Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3350 |