The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Accurate Beta 30 Pregnancy Test Kit.
| Device ID | K841602 |
| 510k Number | K841602 |
| Device Name: | ACCURATE BETA 30 PREGNANCY TEST KIT |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | ORGANON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-18 |
| Decision Date | 1984-05-22 |