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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemoglobinometer
510(k) Number K973995
Device Name RANDOX BILIRUBIN
Applicant
Randox Laboratories, Ltd.
Ardmore, Diamond Rd.
Crumlin,  IE BT29 4QY
Applicant Contact P ARMSTRONG
Correspondent
Randox Laboratories, Ltd.
Ardmore, Diamond Rd.
Crumlin,  IE BT29 4QY
Correspondent Contact P ARMSTRONG
Regulation Number864.7500
Classification Product Code
GIG  
Date Received10/21/1997
Decision Date 12/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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