Organon, Inc.
Medical device manufacturer in Jersey City, NJ.
42510(k) clearances
0PMA approvals
0recalls
Device types
- JHJ Agglutination Method, Human Chorionic… 11
- JHI Visual, Pregnancy Hcg, Prescription Use 4
- GIM Tubes, Vacuum Sample, With Anticoagulant 2
- KTN System, Test, Infectious Mononucleosis 2
- DHR System, Test, Rheumatoid Factor 2
- GOK Antisera, Hai (Including Hai Control)… 2
- LCX Kit, Test, Pregnancy, Hcg, Over The Counter 2
- KXT Enzyme Immunoassay, Digoxin 2
- JQX Nephelometer, For Clinical Use 1
- OQY Intrauterine Tamponade Balloon 1
- FPK Tubing, Fluid Delivery 1
- JOJ Indicator, Physical/Chemical Sterilization… 1
- KLI Enzyme Immunoassay, Non-Radiolabeled, Total… 1
- KHQ Radioassay, Triiodothyronine Uptake 1
- GTZ Antisera, All Groups, Streptococcus Spp. 1
- JJT Enzyme Controls (Assayed And Unassayed) 1
- DEW Igg, Antigen, Antiserum, Control 1
- CDX Radioimmunoassay, Total Thyroxine 1
- JMM Column Chromatography & Color Development… 1
- FQZ Thermometer, Clinical Color Change 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253642 | Jada System (Jada-2002)OQY · Traditional | 05/15/2026SE |
| K950861 | Reconstitution AccessoreisFPK · Traditional | 05/26/1995SE |
| K853388 | Monosticon Uni-DotKTN · Traditional | 08/22/1985SE |
| K842314 | Duoclon Color-CeptJHJ · Traditional | 08/24/1984SE |
| K841525 | Oreia II B-Hcg Pregnancy Test KitJHI · Traditional | 06/05/1984SE |
| K841602 | Accurate Beta 30 Pregnancy Test KitLCX · Traditional | 05/22/1984SE |
| K840650 | B-Neocept 30JHJ · Traditional | 04/04/1984SE |
| K832801 | Oreia II B-Hcg, Enzyme InnunoassayJHI · Traditional | 12/08/1983SE |
| K831339 | Neo-Pregnosticon Duoclon Tube TestJHJ · Traditional | 06/08/1983SE |
| K831109 | Duoclon Slide TestJHI · Traditional | 06/02/1983SE |
| K823682 | Beta Ffirm TestJHJ · Traditional | 01/07/1983SE |
| K812967 | Accurate BetaJHJ · Traditional | 11/06/1981SE |
| K812334 | B-NeoceptJHJ · Traditional | 09/01/1981SE |
| K812261 | Accurate IJHJ · Traditional | 08/31/1981SE |
| K811940 | Oreia II, B-HcgJHJ · Traditional | 08/03/1981SE |
| K811941 | NeoceptJHJ · Traditional | 07/27/1981SE |
| K802974 | Rapi-DotJHJ · Traditional | 12/19/1980SE |
| K802634 | Sterigage Eo Ethyl. Oxide Steril. Indic.JOJ · Traditional | 12/11/1980SE |
| K802693 | Oreia-Q-Ty, Enzyme ImmunoassayKLI · Traditional | 12/10/1980SE |
| K802464 | Oreai-Q-Tu TestKHQ · Traditional | 10/31/1980SE |
| K802358 | Oreia-Q-DigKXT · Traditional | 10/10/1980SE |
| K801159 | Strepto-Sec TMGTZ · Traditional | 06/20/1980SE |
| K791172 | Oreia-Tu Thyroid Uptaker Ratio Assay · Traditional | 10/30/1979SE |
| K791723 | Quantaffirm CPK Iso Enzyme Serum (Human)JJT · Traditional | 10/01/1979SE |
| K790734 | Pregnosticon Pregnancy Test KitJHJ · Traditional | 06/15/1979SE |
| K790521 | Oreia - DigoxinKXT · Traditional | 04/10/1979SE |
| K790122 | RubanonGOK · Traditional | 02/15/1979SE |
| K781554 | RAD-291JQX · Traditional | 10/11/1978SE |
| K780308 | OREIA-T4CDX · Traditional | 04/12/1978SE |
| K780240 | PredictorLCX · Traditional | 02/27/1978SE |
| K780063 | RubenosticonGOK · Traditional | 01/20/1978SE |
| K772086 | Quantrols HCGJHI · Traditional | 11/23/1977SE |
| K771941 | Quantrols Im · Traditional | 11/02/1977SE |
| K771940 | Quantrols RFDHR · Traditional | 11/02/1977SE |
| K771410 | Rheumanosticon RDHR · Traditional | 09/02/1977SE |
| K770603 | Hypronosticon TMJMM · Traditional | 09/02/1977SE |
| K771397 | Monosticon TestKTN · Traditional | 08/22/1977SE |
| K771305 | Liquaemin Sodium, Heparin Sodium Etc.GIM · Traditional | 08/04/1977SE |
| K771304 | Liquaemib Sodium Preservative, Etc.GIM · Traditional | 08/04/1977SE |
| K771038 | Thermometer, Single Use, Strip, TempadotFQZ · Traditional | 06/27/1977SE |
| K770605 | Tubes, Hydrolysis, Calibrated · Traditional | 06/15/1977SE |
| K770597 | Dasp TM Anti-RabbitDEW · Traditional | 04/28/1977SE |