# Organon, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 42 (1977–2026): 42 510(k) clearances
- Names in FDA's records: Organon, Inc. (41); Organon, LLC (1)
- Product codes: JHJ (11), JHI (4), KXT (2), DHR (2), LCX (2), GIM (2), KTN (2), GOK (2), KLI (1), JJT (1), KHQ (1), FQZ (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Alydia Health: 1 (https://510kreport.com/company/alydia-health)

## Recent decisions
- K253642: Jada System (Jada-2002) (May 15, 2026)
- K950861: Reconstitution Accessoreis (May 26, 1995)
- K853388: Monosticon Uni-Dot (Aug 22, 1985)
- K842314: Duoclon Color-Cept (Aug 24, 1984)
- K841525: Oreia II B-HCG Pregnancy Test Kit (Jun 5, 1984)
- K841602: Accurate Beta 30 Pregnancy Test Kit (May 22, 1984)
- K840650: B-Neocept 30 (Apr 4, 1984)
- K832801: Oreia II B-HCG, Enzyme Innunoassay (Dec 8, 1983)

Source page: https://510kreport.com/company/organon