Cenogenics Corp.
Morganville, NJ, US
CENOGENICS CORP. appears in FDA device records in Morganville, NJ. FDA records list 5 510(k) clearances between and , no 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 5 510(k) clearances for Cenogenics Corp. between 1985 and 2005. The busiest year on record is 1985, with 1. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1989 | 1 |
| 1999 | 1 |
| 2003 | 1 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K042641 | CHEMVIEW-10 | JIL | Substantially Equivalent | |
| K030533 | ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST | LCX | Substantially Equivalent | |
| K992397 | ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE | JHI | Substantially Equivalent | |
| K894793 | MONODEX | KTN | Substantially Equivalent | |
| K843680 | URI-VAL | JMZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2250030 | 2250030 | CENOGENICS CORP. | 100 RT. 520, Drawer 308, MORGANVILLE, NJ 07751 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GSOAntigens (Febrile), Agglutination, Brucella Spp.
- GSZAntigens, Febrile (Weil-Felix), All Groups
- GNCAntigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
- GMQAntigens, Nontreponemal, All
- GMPAntisera, Control For Nontreponemal Tests
- GSNAntiserum, Positive And Negative Febrile Antigen Control Serum
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- JMZComparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- KHEReagent, Occult Blood
- IBAStreptolysin O
- DCNSystem, Test, C-Reactive Protein
- KTNSystem, Test, Infectious Mononucleosis
- DHRSystem, Test, Rheumatoid Factor
- 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