The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Nichols Advantage Chemiluminescence Soluble Transferrin Receptor Immunoassay, Model 62-7028.
| Device ID | K992188 |
| 510k Number | K992188 |
| Device Name: | NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028 |
| Classification | Immunochemical, Transferrin |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 33051 CALLE AVIADOR San Juan Capistrano, CA 92675 |
| Contact | James A Rybski |
| Correspondent | James A Rybski NICHOLS INSTITUTE DIAGNOSTICS 33051 CALLE AVIADOR San Juan Capistrano, CA 92675 |
| Product Code | JNM |
| CFR Regulation Number | 866.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-29 |
| Decision Date | 1999-12-06 |
| Summary: | summary |