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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oncometer, Plasma, For Clinical Use
510(k) Number K760975
Device Name WEIL ONCOMETER (IL 186)
Applicant
Instrumentation Laboratory CO
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Instrumentation Laboratory CO
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2720
Classification Product Code
JJK  
Date Received11/03/1976
Decision Date 01/12/1977
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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