The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Duoclon Slide Test.
| Device ID | K831109 |
| 510k Number | K831109 |
| Device Name: | DUOCLON SLIDE TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | ORGANON, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-05 |
| Decision Date | 1983-06-02 |