The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Ria System For Human F-s Hormone.
| Device ID | K780870 |
| 510k Number | K780870 |
| Device Name: | RIA SYSTEM FOR HUMAN F-S HORMONE |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | CALBIOCHEM-BEHRING CORP. 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 | 1978-05-30 |
| Decision Date | 1978-06-22 |