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 BILIRUBIN REAGENT

K-Number: K923609 · 1992-10-02

ApplicantOlympus Corp.
Decision Date1992-10-02
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS TOTAL BILIRUBIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1992-10-02 under 510(k) number K923609. 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 TOTAL BILIRUBIN REAGENT?

OLYMPUS TOTAL BILIRUBIN REAGENT is a medical device that received FDA 510(k) clearance on 1992-10-02. The listed applicant is Olympus Corp.. The 510(k) number is K923609.

When did OLYMPUS TOTAL BILIRUBIN REAGENT receive FDA 510(k) clearance?

OLYMPUS TOTAL BILIRUBIN REAGENT received FDA 510(k) clearance on 1992-10-02, under 510(k) number K923609.

Who is the listed applicant for OLYMPUS TOTAL BILIRUBIN REAGENT?

The FDA 510(k) record lists Olympus Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS TOTAL BILIRUBIN REAGENT?

The FDA product code for OLYMPUS TOTAL BILIRUBIN REAGENT 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 Corp. 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.

K915402EW-10 AND EW-20K933200OLYMPUS PBD STENTSK942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESK931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSK934835FLOVALK931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

View all 142 devices →

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.

↑