Data / Medical devices / United States / Cenogenics Corp.

Cenogenics Corp.: FDA-registered device maker in Morganville, NJ, United States, 5 510(k) clearances

Name: Cenogenics Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cenogenics Corp. is registered with the FDA (registration 2250030) in Morganville, NJ, United States. It lists 15 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 7, 2005. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2250030
Address: 100 RT. 520, Drawer 308, Morganville, NJ, United States, 07751
Owner or operator: CENOGENICS CORPORATION (2243923)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: November 8, 1977
Registered through: 2026
Brand names listed: ACCULYSIN-O, ACCUNATE HOME PREGNANCY TEST, ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ANTI-STREPTOLYSIN CONTROL SERUM, BRUCELLA ABORTUS AND BRU, BRUCELLA ABORTUS AND BRUCELLA MELITENSIS ANTIGENS, CHEMVIEW-10 and more

Devices it lists

Device	Product code	Class	Role	Source
Antigens (Febrile), Agglutination, Brucella Spp.	GSO	2	Manufacturer	accessdata.fda.gov
Antigens, Febrile (Weil-Felix), All Groups	GSZ	1	Manufacturer	accessdata.fda.gov
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.	GNC	2	Manufacturer	accessdata.fda.gov
Antigens, Nontreponemal, All	GMQ	2	Repackager or relabeler	accessdata.fda.gov
Antisera, Control For Nontreponemal Tests	GMP	2	Manufacturer	accessdata.fda.gov
Antiserum, Positive And Negative Febrile Antigen Control Serum	GSN	2	Manufacturer	accessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O Reagent	GTQ	1	Repackager or relabeler	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Repackager or relabeler	accessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	2	Repackager or relabeler	accessdata.fda.gov
Reagent, Occult Blood	KHE	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Streptolysin O	IBA	1	Repackager or relabeler	accessdata.fda.gov
System, Test, C-Reactive Protein	DCN	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Test, Infectious Mononucleosis	KTN	2	Manufacturer	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 7, 2005	K042641	CHEMVIEW-10	JIL	Substantially Equivalent	Cenogenics Corp.	accessdata.fda.gov
April 17, 2003	K030533	ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST	LCX	Substantially Equivalent	Cenogenics Corp.	accessdata.fda.gov
August 26, 1999	K992397	ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE	JHI	Substantially Equivalent	Cenogenics Corp.	accessdata.fda.gov
August 21, 1989	K894793	MONODEX	KTN	Substantially Equivalent	Cenogenics Corp.	accessdata.fda.gov
December 21, 1976	K761232	QUICK CULT SLIDE TEST FECAL OCCULT BLOOD	KHE	Substantially Equivalent	Laboratory Diagnostics Co., Inc.	accessdata.fda.gov

Compare with other makers

Updated January 7, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.