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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K972287
Device Name DADE TRU-LIQUID BILIRUBIN CONTROL
Applicant
Dade Intl., Inc.
2173 NW 99th Ave.
Miami,  FL  33172
Applicant Contact RADHA GOOLABSINGH
Correspondent
Dade Intl., Inc.
2173 NW 99th Ave.
Miami,  FL  33172
Correspondent Contact RADHA GOOLABSINGH
Regulation Number862.1660
Classification Product Code
JJX  
Date Received06/19/1997
Decision Date 07/07/1997
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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