Olympus Total BHCG Test Systen

Q: What is the product code of K080094?

The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.

FDA 510(k) K080094 · Olympus Life Science Research Europa GmbH (Europa)

Substantially Equivalent

510(k) numberK080094

Submission

Device name: Olympus Total BHCG Test Systen
Applicant: Olympus Life Science Research Europa GmbH (Europa)
Irving, TX, US
Received: January 14, 2008
Decision date: September 3, 2008
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: DHA – System, Test, Human Chorionic Gonadotropin
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1155
Specialty: Clinical Chemistry

Other 510(k)s with product code DHA

510(k)	Device	Applicant	Decision
K233581	VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional	Ortho Clinical Diagnostics	05/08/2024SE
K223690	iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)DHA · Traditional	Shenzhen Yhlo Biotech Co., Ltd.	12/11/2023SE
K230937	Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA · Traditional	Abbott Laboratories	06/05/2023SE
K230790	Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample…DHA · Traditional	Abbott Laboratories	05/19/2023SE
K221990	Access Total ßhCG (5th IS)DHA · Traditional	Beckman Coulter, Inc.	12/27/2022SE
K212221	Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800…DHA · Traditional	Diazyme Laboratories, Inc.	12/13/2021SE
K203227	Elecsys HCG STATDHA · Traditional	Roche Diagnostics	08/18/2021SE
K200210	ADVIA Centaur® Total hCG assayDHA · Traditional	Siemens Healthcare Diagnostics, Inc.	07/13/2021SE
K192547	MAGLUMI 2000 HCG/ß-HCGDHA · Traditional	Shenzhen New Industries Biomedical Engineering…	01/17/2020SE
K192790	Atellica IM Total hCG (ThCG)DHA · Traditional	Siemens Healthcare Diagnostics, Inc.	10/30/2019SE

More from Siemens Healthcare Diagnostics, Inc.

510(k)	Device	Decision
K081709	Olympus Afp - Alpha-FetoproteinLOJ · Traditional	03/16/2009SE
K080435	Olympus Direct Bilirubin Reagent, Model OSR6X181CIG · Traditional	09/05/2008SE

Questions and answers

When was Olympus Total BHCG Test Systen cleared by the FDA?

Olympus Total BHCG Test Systen (K080094) received a 510(k) decision of Substantially Equivalent on September 3, 2008, 233 days after the submission was received.

What is the product code of K080094?

The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.