The following data is part of a premarket notification filed by Pcl-ria, Inc. with the FDA for B-gcg System By Ria.
Device ID | K830526 |
510k Number | K830526 |
Device Name: | B-GCG SYSTEM BY RIA |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | PCL-RIA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-17 |
Decision Date | 1983-04-05 |