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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 K771089
Device Name UNIPAK TOTAL BILIRUBIN
Applicant
HARLECO
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HARLECO
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1110
Classification Product Code
CIG  
Date Received06/16/1977
Decision Date 07/21/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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