The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Pregnosticon Pregnancy Test Kit.
| Device ID | K790734 |
| 510k Number | K790734 |
| Device Name: | PREGNOSTICON PREGNANCY TEST KIT |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | ORGANON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-04-16 |
| Decision Date | 1979-06-15 |