The following data is part of a premarket notification filed by Ria Products, Inc. with the FDA for No-boil Folate Kit #rp-500.
| Device ID | K800914 |
| 510k Number | K800914 |
| Device Name: | NO-BOIL FOLATE KIT #RP-500 |
| Classification | Acid, Folic, Radioimmunoassay |
| Applicant | RIA PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGN |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-21 |
| Decision Date | 1980-05-08 |