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FDA 510(k)

DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176

K-Number: K904468 · 1991-01-17

ApplicantAmresco, Inc.
Decision Date1991-01-17
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 is the device name listed in this FDA 510(k) record. The listed applicant is Amresco, Inc.. It received FDA 510(k) clearance on 1991-01-17 under 510(k) number K904468. 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 DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176?

DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 is a medical device that received FDA 510(k) clearance on 1991-01-17. The listed applicant is Amresco, Inc.. The 510(k) number is K904468.

When did DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 receive FDA 510(k) clearance?

DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 received FDA 510(k) clearance on 1991-01-17, under 510(k) number K904468.

Who is the listed applicant for DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176?

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 DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176?

The FDA product code for DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 is CIG.

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Other records listing Amresco, Inc. as applicant

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K905618GGT REAGENTK905684ALKALINE PHOSPHATASEK905544MAGNESIUM REAGENTK905284HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173K904004AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116K905096GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138

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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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