The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Progesterone Direct Ria Kit (125i).
| Device ID | K811907 |
| 510k Number | K811907 |
| Device Name: | PROGESTERONE DIRECT RIA KIT (125I) |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | Immunalysis Corporation 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-01 |
| Decision Date | 1981-07-23 |