The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Human Chorionic Gonadotropin Visual Test Kit.
| Device ID | K880410 |
| 510k Number | K880410 |
| Device Name: | HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
| Contact | Siegfried Krutzik |
| Correspondent | Siegfried Krutzik DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-01 |
| Decision Date | 1988-04-05 |