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

Name: FDA 510(k) clearance K972382
Creator: U.S. Food and Drug Administration
Published: 1998-09-14

Substantially Equivalent

Arrows Co., Ltd.

FDA 510(k) clearance K972382 for UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL, Substantially Equivalent on 1998-09-14. Applicant: Arrows Co., Ltd.. Device class: 2.

Clearance details

Applicant: Arrows Co., Ltd.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1997-06-26
Decision date: 1998-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Osaka, JP

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