The following data is part of a premarket notification filed by Biogenex Laboratories with the FDA for Riagen Pap Ria.
| Device ID | K813261 |
| 510k Number | K813261 |
| Device Name: | RIAGEN PAP RIA |
| Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
| Applicant | BIOGENEX LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JFH |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-20 |
| Decision Date | 1981-12-17 |