The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Pregnospia Ii.
| Device ID | K881435 |
| 510k Number | K881435 |
| Device Name: | PREGNOSPIA II |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | ORGANON TEKNIKA CORP. 800 CAPITOLA DR. Durham, NC 27713 |
| Contact | Sheldon Mazursky |
| Correspondent | Sheldon Mazursky ORGANON TEKNIKA CORP. 800 CAPITOLA DR. Durham, NC 27713 |
| Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-05 |
| Decision Date | 1988-05-27 |