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FDA 510(k)

DIAZO COLORIMENTRY DIRECT BILIRUBIN

K-Number: K904381 · 1990-10-12

ApplicantAmresco, Inc.
Decision Date1990-10-12
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAZO COLORIMENTRY DIRECT BILIRUBIN is the device name listed in this FDA 510(k) record. The listed applicant is Amresco, Inc.. It received FDA 510(k) clearance on 1990-10-12 under 510(k) number K904381. 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 DIAZO COLORIMENTRY DIRECT BILIRUBIN?

DIAZO COLORIMENTRY DIRECT BILIRUBIN is a medical device that received FDA 510(k) clearance on 1990-10-12. The listed applicant is Amresco, Inc.. The 510(k) number is K904381.

When did DIAZO COLORIMENTRY DIRECT BILIRUBIN receive FDA 510(k) clearance?

DIAZO COLORIMENTRY DIRECT BILIRUBIN received FDA 510(k) clearance on 1990-10-12, under 510(k) number K904381.

Who is the listed applicant for DIAZO COLORIMENTRY DIRECT BILIRUBIN?

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

What is the FDA product code for DIAZO COLORIMENTRY DIRECT BILIRUBIN?

The FDA product code for DIAZO COLORIMENTRY DIRECT BILIRUBIN is CIG.

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Other records listing Amresco, Inc. 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.

K905618GGT REAGENTK904468DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176K905684ALKALINE PHOSPHATASEK905544MAGNESIUM REAGENTK905284HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173K904004AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116

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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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