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FDA 510(k)

GILCHEM TOTAL BILIRUBIN REAGENT

K-Number: K831843 · 1983-07-18

ApplicantGilford Diagnostics
Decision Date1983-07-18
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GILCHEM TOTAL BILIRUBIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1983-07-18 under 510(k) number K831843. 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 GILCHEM TOTAL BILIRUBIN REAGENT?

GILCHEM TOTAL BILIRUBIN REAGENT is a medical device that received FDA 510(k) clearance on 1983-07-18. The listed applicant is Gilford Diagnostics. The 510(k) number is K831843.

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

GILCHEM TOTAL BILIRUBIN REAGENT received FDA 510(k) clearance on 1983-07-18, under 510(k) number K831843.

Who is the listed applicant for GILCHEM TOTAL BILIRUBIN REAGENT?

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

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

The FDA product code for GILCHEM TOTAL BILIRUBIN REAGENT is CIG.

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Other records listing Gilford Diagnostics 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.

K832094BILIRUBIN CALIBRATORS & CONTROLK831844DIRECT BILIRUBIN REAGENTK823709TRIGLYCERIDE REAGENT (UV)K822739AHBDK822334BILIRUBIN CALIBRATORSK822289CO2/CI STANDARDS

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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

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

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