The following data is part of a premarket notification filed by Corning Nichols Diagnostics with the FDA for Insulin-like Growth Factor-i (igf-i) Immunoradiometric Assay.
| Device ID | K955390 |
| 510k Number | K955390 |
| Device Name: | INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY |
| Classification | Radioimmunoassay, Human Growth Hormone |
| Applicant | CORNING NICHOLS DIAGNOSTICS 33061 CALLE AVIADOR San Juan Capistrano, CA 92675 |
| Contact | Dave D Smith |
| Correspondent | Dave D Smith CORNING NICHOLS DIAGNOSTICS 33061 CALLE AVIADOR San Juan Capistrano, CA 92675 |
| Product Code | CFL |
| CFR Regulation Number | 862.1370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-24 |
| Decision Date | 1995-12-29 |