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FDA 510(k)

ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR

K-Number: K030003 · 2003-09-29

ApplicantElan Diagnostics
Decision Date2003-09-29
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Elan Diagnostics. It received FDA 510(k) clearance on 2003-09-29 under 510(k) number K030003. 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 ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR?

ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR is a medical device that received FDA 510(k) clearance on 2003-09-29. The listed applicant is Elan Diagnostics. The 510(k) number is K030003.

When did ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR receive FDA 510(k) clearance?

ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR received FDA 510(k) clearance on 2003-09-29, under 510(k) number K030003.

Who is the listed applicant for ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR?

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

What is the FDA product code for ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR?

The FDA product code for ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR is CIG.

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Other records listing Elan 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.

K030014ATAC TOTAL BILIRUBIN REAGENTK030621ATAC CALIBRATORK023105ATAC CALCIUM REAGENT AND ATAC CALIBRATORK030010ATAC PAK MAGNESIUM REAGENTK030015ATAC PAK PHOSPHORUS REAGENTK030006ATAC PAK ALBUMIN REAGENT

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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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