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FDA 510(k)

OLYMPUS DIRECT BILIRUBIN REAGENT

K-Number: K923608 · 1992-08-18

ApplicantOlympus Corp.
Decision Date1992-08-18
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS DIRECT 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 1992-08-18 under 510(k) number K923608. 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?

OLYMPUS DIRECT BILIRUBIN REAGENT is a medical device that received FDA 510(k) clearance on 1992-08-18. The listed applicant is Olympus Corp.. The 510(k) number is K923608.

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

OLYMPUS DIRECT BILIRUBIN REAGENT received FDA 510(k) clearance on 1992-08-18, under 510(k) number K923608.

Who is the listed applicant for OLYMPUS DIRECT 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 DIRECT BILIRUBIN REAGENT?

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

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Other records listing Olympus Corp. as applicant

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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

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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.

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