Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OLYMPUS TOTAL BHCG TEST SYSTEN

K-Number: K080094 · 2008-09-03

ApplicantOlympus Life Science Research Europa GmbH (Europa)
Decision Date2008-09-03
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS TOTAL BHCG TEST SYSTEN is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Life Science Research Europa GmbH (Europa). It received FDA 510(k) clearance on 2008-09-03 under 510(k) number K080094. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS TOTAL BHCG TEST SYSTEN?

OLYMPUS TOTAL BHCG TEST SYSTEN is a medical device that received FDA 510(k) clearance on 2008-09-03. The listed applicant is Olympus Life Science Research Europa GmbH (Europa). The 510(k) number is K080094.

When did OLYMPUS TOTAL BHCG TEST SYSTEN receive FDA 510(k) clearance?

OLYMPUS TOTAL BHCG TEST SYSTEN received FDA 510(k) clearance on 2008-09-03, under 510(k) number K080094.

Who is the listed applicant for OLYMPUS TOTAL BHCG TEST SYSTEN?

The FDA 510(k) record lists Olympus Life Science Research Europa GmbH (Europa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS TOTAL BHCG TEST SYSTEN?

The FDA product code for OLYMPUS TOTAL BHCG TEST SYSTEN is DHA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Olympus Life Science Research Europa GmbH (Europa) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K081709OLYMPUS AFP - ALPHA-FETOPROTEINK080435OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181

Related Devices (Code: DHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical DiagnosticsK223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd.K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott LaboratoriesK230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-seriesAbbott LaboratoriesK221990Access Total ßhCG (5th IS)Beckman Coulter, Inc.K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑