The following data is part of a premarket notification filed by Pantex with the FDA for Neoscreen Elisa Hydroxyprogesterone.
| Device ID | K940233 |
| 510k Number | K940233 |
| Device Name: | NEOSCREEN ELISA HYDROXYPROGESTERONE |
| Classification | Radioimmunoassay, 17-hydroxyprogesterone |
| Applicant | PANTEX 1737 21ST ST. Santa Monica, CA 90404 |
| Contact | Nancy Chow |
| Correspondent | Nancy Chow PANTEX 1737 21ST ST. Santa Monica, CA 90404 |
| Product Code | JLX |
| CFR Regulation Number | 862.1395 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-18 |
| Decision Date | 1994-12-28 |