The following data is part of a premarket notification filed by Ramco Laboratories, Inc. with the FDA for Epo-ria.
| Device ID | K910481 |
| 510k Number | K910481 |
| Device Name: | EPO-RIA |
| Classification | Assay, Erythropoietin |
| Applicant | RAMCO LABORATORIES, INC. 4507 MT.VERNON Houston, TX 77006 |
| Contact | Candice Gorin |
| Correspondent | Candice Gorin RAMCO LABORATORIES, INC. 4507 MT.VERNON Houston, TX 77006 |
| Product Code | GGT |
| CFR Regulation Number | 864.7250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-06 |
| Decision Date | 1991-11-29 |