The following data is part of a premarket notification filed by Nichols Institute with the FDA for Insulin-like Growth Factor I (igf-i), Immunoradiometeric Assay (irma).
| Device ID | K952505 |
| 510k Number | K952505 |
| Device Name: | INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) |
| Classification | Radioimmunoassay, Human Growth Hormone |
| Applicant | NICHOLS INSTITUTE 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 |
| Contact | Dave D Smith |
| Correspondent | Dave D Smith NICHOLS INSTITUTE 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 |
| Product Code | CFL |
| CFR Regulation Number | 862.1370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-31 |
| Decision Date | 1995-07-03 |