The following data is part of a premarket notification filed by Ria Products, Inc. with the FDA for No-hoil Combostat Ii Kit.
| Device ID | K813310 |
| 510k Number | K813310 |
| Device Name: | NO-HOIL COMBOSTAT II KIT |
| Classification | Radioassay, Vitamin B12 |
| Applicant | RIA PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-24 |
| Decision Date | 1981-12-17 |