K834246 is an FDA 510(k) clearance for the PROGESTERONE TEST SET 125I 17-OH. This device is classified as a Radioimmunoassay, 17-hydroxyprogesterone (Class I - General Controls, product code JLX).
Submitted by Wien Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984, 59 days after receiving the submission on December 7, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1395.
| 510(k) Number | K834246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1983 |
| Decision Date | February 04, 1984 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JLX — Radioimmunoassay, 17-hydroxyprogesterone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1395 |