Organon LLC
Jersey City, NJ, US
Organon LLC appears in FDA device records in Jersey City, NJ. FDA records list 42 510(k) clearances between and , 2 PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 42 510(k) clearances for Organon LLC between 1977 and 2026. The busiest year on record is 1977, with 11. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 11 |
| 1978 | 4 |
| 1979 | 5 |
| 1980 | 6 |
| 1981 | 5 |
| 1983 | 4 |
| 1984 | 4 |
| 1985 | 1 |
| 1995 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253642 | Jada System (Jada-2002) | OQY | Substantially Equivalent | |
| K950861 | RECONSTITUTION ACCESSOREIS | FPK | Substantially Equivalent | |
| K853388 | MONOSTICON UNI-DOT | KTN | Substantially Equivalent | |
| K842314 | DUOCLON COLOR-CEPT | JHJ | Substantially Equivalent | |
| K841525 | OREIA II B-HCG PREGNANCY TEST KIT | JHI | Substantially Equivalent | |
| K841602 | ACCURATE BETA 30 PREGNANCY TEST KIT | LCX | Substantially Equivalent | |
| K840650 | B-NEOCEPT 30 | JHJ | Substantially Equivalent | |
| K832801 | OREIA II B-HCG, ENZYME INNUNOASSAY | JHI | Substantially Equivalent | |
| K831339 | NEO-PREGNOSTICON DUOCLON TUBE TEST | JHJ | Substantially Equivalent | |
| K831109 | DUOCLON SLIDE TEST | JHI | Substantially Equivalent | |
| K823682 | BETA FFIRM TEST | JHJ | Substantially Equivalent | |
| K812967 | ACCURATE BETA | JHJ | Substantially Equivalent | |
| K812334 | B-NEOCEPT | JHJ | Substantially Equivalent | |
| K812261 | ACCURATE I | JHJ | Substantially Equivalent | |
| K811940 | OREIA II, B-HCG | JHJ | Substantially Equivalent | |
| K811941 | NEOCEPT | JHJ | Substantially Equivalent | |
| K802974 | RAPI-DOT | JHJ | Substantially Equivalent | |
| K802634 | STERIGAGE EO ETHYL. OXIDE STERIL. INDIC. | JOJ | Substantially Equivalent | |
| K802693 | OREIA-Q-TY, ENZYME IMMUNOASSAY | KLI | Substantially Equivalent | |
| K802464 | OREAI-Q-TU TEST | KHQ | Substantially Equivalent | |
| K802358 | OREIA-Q-DIG | KXT | Substantially Equivalent | |
| K801159 | STREPTO-SEC TM | GTZ | Substantially Equivalent | |
| K791172 | OREIA-TU THYROID UPTAKER RATIO ASSAY | Substantially Equivalent | ||
| K791723 | QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN) | JJT | Substantially Equivalent | |
| K790734 | PREGNOSTICON PREGNANCY TEST KIT | JHJ | Substantially Equivalent | |
| K790521 | OREIA - DIGOXIN | KXT | Substantially Equivalent | |
| K790122 | RUBANON | GOK | Substantially Equivalent | |
| K781554 | RAD-291 | JQX | Substantially Equivalent | |
| K780308 | OREIA-T4 | CDX | Substantially Equivalent | |
| K780240 | PREDICTOR | LCX | Substantially Equivalent | |
| K780063 | RUBENOSTICON | GOK | Substantially Equivalent | |
| K772086 | QUANTROLS HCG | JHI | Substantially Equivalent | |
| K771941 | QUANTROLS IM | Substantially Equivalent | ||
| K771940 | QUANTROLS RF | DHR | Substantially Equivalent | |
| K771410 | RHEUMANOSTICON R | DHR | Substantially Equivalent | |
| K770603 | HYPRONOSTICON TM | JMM | Substantially Equivalent | |
| K771397 | MONOSTICON TEST | KTN | Substantially Equivalent | |
| K771305 | LIQUAEMIN SODIUM, HEPARIN SODIUM ETC. | GIM | Substantially Equivalent | |
| K771304 | LIQUAEMIB SODIUM PRESERVATIVE, ETC. | GIM | Substantially Equivalent | |
| K771038 | THERMOMETER, SINGLE USE, STRIP, TEMPADOT | FQZ | Substantially Equivalent | |
| K770605 | TUBES, HYDROLYSIS, CALIBRATED | Substantially Equivalent | ||
| K770597 | DASP TM ANTI-RABBIT | DEW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017425145 | 3017425145 | Organon LLC | 30 Hudson Street, Jersey City, NJ 07302 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JHJAgglutination Method, Human Chorionic Gonadotropin
- GTZAntisera, All Groups, Streptococcus Spp.
- GOKAntisera, Hai (Including Hai Control), Rubella
- HGDApplicator, Vaginal
- JMMColumn Chromatography & Color Development, Hydroxyproline
- JJTEnzyme Controls (Assayed And Unassayed)
- KXTEnzyme Immunoassay, Digoxin
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DEWIgg, Antigen, Antiserum, Control
- JOJIndicator, Physical/Chemical Sterilization Process
- OQYIntrauterine Tamponade Balloon
- JSXKit, Identification, Neisseria Gonorrhoeae
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- JQXNephelometer, For Clinical Use
- KHQRadioassay, Triiodothyronine Uptake
- CDXRadioimmunoassay, Total Thyroxine
- KTNSystem, Test, Infectious Mononucleosis
- DHRSystem, Test, Rheumatoid Factor
- FQZThermometer, Clinical Color Change
- GIMTubes, Vacuum Sample, With Anticoagulant
- FPKTubing, Fluid Delivery
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain