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FDA 510(k)

UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL

K-Number: K972382 · 1998-09-14

ApplicantArrows Co., Ltd.
Decision Date1998-09-14
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Arrows Co., Ltd.. It received FDA 510(k) clearance on 1998-09-14 under 510(k) number K972382. 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 UA-2, REAGENT KIT AND BILIRUBIN CONTROL?

UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL is a medical device that received FDA 510(k) clearance on 1998-09-14. The listed applicant is Arrows Co., Ltd.. The 510(k) number is K972382.

When did UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL receive FDA 510(k) clearance?

UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL received FDA 510(k) clearance on 1998-09-14, under 510(k) number K972382.

Who is the listed applicant for UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL?

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

What is the FDA product code for UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL?

The FDA product code for UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL is CIG.

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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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