K833406 is an FDA 510(k) clearance for the IMMOPHASE D-TE 3 RADIOIMMUNOASSAY. This device is classified as a Radioimmunoassay, Estrone (Class I - General Controls, product code CGF).
Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on January 24, 1984, 116 days after receiving the submission on September 30, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1280.
| 510(k) Number | K833406 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 1983 |
| Decision Date | January 24, 1984 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CGF — Radioimmunoassay, Estrone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1280 |