The following data is part of a premarket notification filed by Ria Products, Inc. with the FDA for Ria For Folates & Vit. B12, Combo Kit.
Device ID | K780148 |
510k Number | K780148 |
Device Name: | RIA FOR FOLATES & VIT. B12, COMBO KIT |
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 | 1978-01-30 |
Decision Date | 1978-03-03 |