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 DIRECT BILIRUBIN REAGENT, MODEL OSR6X181

K-Number: K080435 · 2008-09-05

ApplicantOlympus Life Science Research Europa GmbH (Europa)
Decision Date2008-09-05
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 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 2008-09-05 under 510(k) number K080435. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181?

OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 is a medical device that received FDA 510(k) clearance on 2008-09-05. The listed applicant is Olympus Life Science Research Europa GmbH (Europa). The 510(k) number is K080435.

When did OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 receive FDA 510(k) clearance?

OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 received FDA 510(k) clearance on 2008-09-05, under 510(k) number K080435.

Who is the listed applicant for OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181?

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 DIRECT BILIRUBIN REAGENT, MODEL OSR6X181?

The FDA product code for OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 is CIG.

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-FETOPROTEINK080094OLYMPUS TOTAL BHCG TEST SYSTEN

Related Devices (Code: CIG)

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.

K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc.K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223324Total Bilirubin2Abbott Ireland Diagnostics DivisionK190807VITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, Inc.K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1Elitechgroup

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.

↑