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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 K842809
Device Name TECHNICON RA-1000 SYS, DIRECT BILIRUBIN
Applicant
Technicon Instruments Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Technicon Instruments Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1110
Classification Product Code
CIG  
Date Received07/18/1984
Decision Date 08/17/1984
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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