FDA 510(k), K972382, UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL

FDA 510(k), K972382, UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL

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510(K) Number: K972382
Device Name: UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL
Manufacturer: ARROWS CO., LTD.
Device Classification Name: Diazo Colorimetry, Bilirubin
Regulation Number: 862.1110
Classification Product Code: CIG
Date Received: 06/26/1997
Decision Date: 09/14/1998
Regulation Medical Specialty: Clinical Chemistry

511 pages (13 of 524 original pages are fully redacted)

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