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 |