Elecsys Ca 125II on the Elecsys 1010

Q: What is the product code of K980240?

The FDA product code is LTK – Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125), a Class II (moderate risk) device regulated under 21 CFR 866.6010.

FDA 510(k) K980240 · Boehringer Mannheim Corp.

Substantially Equivalent

510(k) numberK980240

Submission

Device name: Elecsys Ca 125II on the Elecsys 1010
Applicant: Boehringer Mannheim Corp.
Pleasanton, CA, US
Received: January 23, 1998
Decision date: March 25, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LTK – Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.6010
Specialty: Immunology

Other 510(k)s with product code LTK

510(k)	Device	Applicant	Decision
K240479	Access OV MonitorLTK · Traditional	Beckman Coulter, Inc.	05/10/2024SE
K213510	Immulite/Immulite 1000 Om-Ma, Immulite 2000 Om-MaLTK · Traditional	Siemens Healthcare Diagnostics Products, Ltd.	09/08/2023SE
K221355	VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK · Traditional	Ortho Clinical Diagnostics	12/12/2022SE
K200199	ADVIA Centaur CA 125IILTK · Traditional	Siemens Healthcare Diagnostics, Inc.	04/06/2020SE
K143534	Elecsys CA-125 II assayLTK · Traditional	Roche Professional Diagnostics	08/06/2015SE
K142895	LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA…LTK · Traditional	Fujirebio Diagnostics,Inc.	05/21/2015SE
K100321	Dimension Vista Loci Ca 125 Flex Reagent Cartridge,And Dimensions Vista Loci 6 Cal…LTK · Traditional	Siemens Healthcare Diagnostics	04/12/2011SE
K080469	Vidas Ca 15-3 AssayLTK · Traditional	bioMerieux, Inc.	06/22/2009SE
K080561	Vidas Ca 125 II AssayLTK · Traditional	bioMerieux, Inc.	04/10/2009SE
K072794	Immulite 2500 Om-Ma, Model L5KOPLTK · Special	Siemens Medical Solutions Diagnostics	11/05/2007SE

More from Siemens Medical Solutions Diagnostics

510(k)	Device	Decision
K984326	Elecys Ige AssayJHR · Traditional	02/08/1999SE
K983047	Accu-Chek HQ SystemLFR · Traditional	02/05/1999SE
K984419	Elecsys Ige CalcheckJJY · Traditional	02/02/1999SE
K984425	Modification of Preciset Serum Proteins CalibratorJIX · Traditional	01/20/1999SE
K984372	Elecsys Calcheck Troponin TJJY · Traditional	12/14/1998SE
K984105	Elecsys Troponin T Stat TestMMI · Traditional	12/08/1998SE
K983503	Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional	12/01/1998SE
K983469	Preciset Serum Proteins CalibratorJIX · Traditional	11/25/1998SE
K983185	Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional	11/12/1998SE
K983510	Chemstrip 101 Urine AnalyzerKQO · Special	10/27/1998SE

Questions and answers

When was Elecsys Ca 125II on the Elecsys 1010 cleared by the FDA?

Elecsys Ca 125II on the Elecsys 1010 (K980240) received a 510(k) decision of Substantially Equivalent on March 25, 1998, 61 days after the submission was received.

What is the product code of K980240?

The FDA product code is LTK – Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125), a Class II (moderate risk) device regulated under 21 CFR 866.6010.