The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Advantage Chemiluminescence Erythropoietin Immunoassay.
| Device ID | K980737 |
| 510k Number | K980737 |
| Device Name: | ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY |
| Classification | Assay, Erythropoietin |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 33051 CALLE AVIADOR San Juan Capistrano, CA 92675 |
| Contact | Jimmy Wong |
| Correspondent | Jimmy Wong NICHOLS INSTITUTE DIAGNOSTICS 33051 CALLE AVIADOR San Juan Capistrano, CA 92675 |
| Product Code | GGT |
| CFR Regulation Number | 864.7250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-25 |
| Decision Date | 1999-03-23 |
| Summary: | summary |