The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Lh (125i) Radioimmunoassay.
| Device ID | K822288 |
| 510k Number | K822288 |
| Device Name: | LH (125I) RADIOIMMUNOASSAY |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-30 |
| Decision Date | 1982-09-13 |