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FDA 510(k)

DIRECT BILIRUBIN

K-Number: K930679 · 1993-06-29

ApplicantHorizon Diagnostics, Inc.
Decision Date1993-06-29
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT BILIRUBIN is the device name listed in this FDA 510(k) record. The listed applicant is Horizon Diagnostics, Inc.. It received FDA 510(k) clearance on 1993-06-29 under 510(k) number K930679. 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?

DIRECT BILIRUBIN is a medical device that received FDA 510(k) clearance on 1993-06-29. The listed applicant is Horizon Diagnostics, Inc.. The 510(k) number is K930679.

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

DIRECT BILIRUBIN received FDA 510(k) clearance on 1993-06-29, under 510(k) number K930679.

Who is the listed applicant for DIRECT BILIRUBIN?

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

What is the FDA product code for DIRECT BILIRUBIN?

The FDA product code for DIRECT BILIRUBIN is CIG.

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Other records listing Horizon Diagnostics, 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.

K971566CREATINE KINASE-MB REAGENT SETK933722HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENTK935712IRON/TIBC REAGENTK930678AMYLASEK934533BUN-300/BUN-500 UREA NITROGEN REAGENTK930074IN-VITRO DIAGNOSTIC REAGENT SET

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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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