The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Follicle Stimulating Hormone Direct Ria.
| Device ID | K811905 |
| 510k Number | K811905 |
| Device Name: | FOLLICLE STIMULATING HORMONE DIRECT RIA |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | Immunalysis Corporation 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-01 |
| Decision Date | 1981-07-23 |