The following data is part of a premarket notification filed by Pcl-ria, Inc. with the FDA for Follicle Stimulating Hormone (fsh).
| Device ID | K810867 |
| 510k Number | K810867 |
| Device Name: | FOLLICLE STIMULATING HORMONE (FSH) |
| Classification | Calibrator, Primary |
| Applicant | PCL-RIA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-31 |
| Decision Date | 1981-04-14 |