The following data is part of a premarket notification filed by Nichols Institute with the FDA for Erythropoietin Immunoassay Kit.
| Device ID | K952559 |
| 510k Number | K952559 |
| Device Name: | ERYTHROPOIETIN IMMUNOASSAY KIT |
| Classification | Assay, Erythropoietin |
| 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 | GGT |
| CFR Regulation Number | 864.7250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-02 |
| Decision Date | 1996-05-29 |