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FDA 510(k)

UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON.

K-Number: K871115 · 1989-01-27

ApplicantLabo Science-USA, Inc.
Decision Date1989-01-27
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON. is the device name listed in this FDA 510(k) record. The listed applicant is Labo Science-USA, Inc.. It received FDA 510(k) clearance on 1989-01-27 under 510(k) number K871115. 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 UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON.?

UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON. is a medical device that received FDA 510(k) clearance on 1989-01-27. The listed applicant is Labo Science-USA, Inc.. The 510(k) number is K871115.

When did UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON. receive FDA 510(k) clearance?

UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON. received FDA 510(k) clearance on 1989-01-27, under 510(k) number K871115.

Who is the listed applicant for UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON.?

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

What is the FDA product code for UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON.?

The FDA product code for UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON. is CIG.

Related Clinical Trials

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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