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
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
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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