The following data is part of a premarket notification filed by Icn Biomedicals, Inc. with the FDA for Immuchem Human Chorionic Gonadotropin Hormone Hcg.
Device ID | K881005 |
510k Number | K881005 |
Device Name: | IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | ICN BIOMEDICALS, INC. P.O. BOX 6227 2015 EAST UNIVERSITY DRIVE Carson, CA 90746 |
Contact | Burns, Phd |
Correspondent | Burns, Phd ICN BIOMEDICALS, INC. P.O. BOX 6227 2015 EAST UNIVERSITY DRIVE Carson, CA 90746 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-09 |
Decision Date | 1988-05-27 |