The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Immo Phase Fsh Radioimmunoassay.
| Device ID | K822227 |
| 510k Number | K822227 |
| Device Name: | IMMO PHASE FSH RADIOIMMUNOASSAY |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | CORNING MEDICAL & SCIENTIFIC 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 | 1982-07-27 |
| Decision Date | 1982-08-16 |