The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Accurate I.
| Device ID | K812261 |
| 510k Number | K812261 |
| Device Name: | ACCURATE I |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | ORGANON, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-12 |
| Decision Date | 1981-08-31 |