Olympus Afp - Alpha-Fetoprotein

Q: What is the product code of K081709?

The FDA product code is LOJ – Kit, Test,Alpha-Fetoprotein For Testicular Cancer, a Class II (moderate risk) device regulated under 21 CFR 866.6010.

FDA 510(k) K081709 · Olympus Life Science Research Europa GmbH (Europa)

Substantially Equivalent

510(k) numberK081709

Submission

Device name: Olympus Afp - Alpha-Fetoprotein
Applicant: Olympus Life Science Research Europa GmbH (Europa)
O'Callaghans Mills, Co. Clare, IE
Received: June 17, 2008
Decision date: March 16, 2009
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: LOJ – Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.6010
Specialty: Immunology

Other 510(k)s with product code LOJ

510(k)	Device	Applicant	Decision
K220176	Elecsys AFPLOJ · Traditional	Roche Diagnostics	09/15/2022SE
K213626	Vitros AfpLOJ · Traditional	Ortho Clinical Diagnostics	06/15/2022SE
K090236	Dimension Vista Afp Flex Reagent Cartridge, Model 6454LOJ · Traditional	Siemens Healthcare Diagnostics	04/27/2009SE
K080017	Vidas Afp AssayLOJ · Traditional	bioMerieux, Inc.	09/26/2008SE
K071597	Dimension Vista (R) Afp Flex(R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci…LOJ · Traditional	Dade Behring, Inc.	06/04/2008SE
K023894	ST Aia-Pack Afp Enzyme ImmunoassayLOJ · Special	Tosoh Medics, Inc.	12/17/2002SE
K020807	Afp Assay for the Advia Integrated Modular SystemLOJ · Traditional	Bayer Diagnostics Corp.	10/01/2002SE
K020806	ACS:180 & Advia Centaur Afp ImmunoassayLOJ · Special	Bayer Corp.	03/27/2002SE
K990138	DSL Active Afp Elisa, Model DSL-10-8400LOJ · Traditional	Diagnostic Systems Laboratories, Inc.	06/21/1999SE
K983031	Vitros Immunodiagnostic Products Afp AssayLOJ · Traditional	Ortho-Clinical Diagnostics, Inc.	12/18/1998SE

More from Ortho-Clinical Diagnostics, Inc.

510(k)	Device	Decision
K080435	Olympus Direct Bilirubin Reagent, Model OSR6X181CIG · Traditional	09/05/2008SE
K080094	Olympus Total BHCG Test SystenDHA · Traditional	09/03/2008SE

Questions and answers

When was Olympus Afp - Alpha-Fetoprotein cleared by the FDA?

Olympus Afp - Alpha-Fetoprotein (K081709) received a 510(k) decision of Substantially Equivalent on March 16, 2009, 272 days after the submission was received.

What is the product code of K081709?

The FDA product code is LOJ – Kit, Test,Alpha-Fetoprotein For Testicular Cancer, a Class II (moderate risk) device regulated under 21 CFR 866.6010.