The following data is part of a premarket notification filed by Wien Laboratories, Inc. with the FDA for Progesterone Test Set 125i 17-oh.
| Device ID | K834246 |
| 510k Number | K834246 |
| Device Name: | PROGESTERONE TEST SET 125I 17-OH |
| Classification | Radioimmunoassay, 17-hydroxyprogesterone |
| Applicant | WIEN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JLX |
| CFR Regulation Number | 862.1395 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-07 |
| Decision Date | 1984-02-04 |