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FDA 510(k)

TRACE TOTAL/DIRECT BILIRUBIN REAGENT

K-Number: K911866 · 1991-07-17

ApplicantTrace Scientific , Ltd.
Decision Date1991-07-17
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRACE TOTAL/DIRECT BILIRUBIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1991-07-17 under 510(k) number K911866. 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 TRACE TOTAL/DIRECT BILIRUBIN REAGENT?

TRACE TOTAL/DIRECT BILIRUBIN REAGENT is a medical device that received FDA 510(k) clearance on 1991-07-17. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K911866.

When did TRACE TOTAL/DIRECT BILIRUBIN REAGENT receive FDA 510(k) clearance?

TRACE TOTAL/DIRECT BILIRUBIN REAGENT received FDA 510(k) clearance on 1991-07-17, under 510(k) number K911866.

Who is the listed applicant for TRACE TOTAL/DIRECT BILIRUBIN REAGENT?

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

What is the FDA product code for TRACE TOTAL/DIRECT BILIRUBIN REAGENT?

The FDA product code for TRACE TOTAL/DIRECT BILIRUBIN REAGENT is CIG.

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Other records listing Trace Scientific , Ltd. 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.

K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTK981123UREAK962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)K961114AST INCORPORATING DSTK961123ALT INCORPORATING DSTK952488TRACE COBAS MIRA RANGE

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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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