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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K972382
Device Name UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL
Applicant
Arrows Co., Ltd.
2-7-50 Nishimiyahara Yodoga-Ku
Osaka,  JP
Applicant Contact YOSHIMASA OGOSHI
Correspondent
Arrows Co., Ltd.
2-7-50 Nishimiyahara Yodoga-Ku
Osaka,  JP
Correspondent Contact YOSHIMASA OGOSHI
Regulation Number862.1110
Classification Product Code
CIG  
Subsequent Product Code
JJX  
Date Received06/26/1997
Decision Date 09/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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