The following data is part of a premarket notification filed by Pcl-ria, Inc. with the FDA for Human Chorionic Gonadotrophin Standards.
Device ID | K790863 |
510k Number | K790863 |
Device Name: | HUMAN CHORIONIC GONADOTROPHIN STANDARDS |
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 | 1979-05-07 |
Decision Date | 1979-07-17 |