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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry, Micro, For Clinical Use
510(k) Number K870777
Device Name PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER
Applicant
KONE INSTRUMENTS, INC.
1110 W. THRONDALE AVE.
BENSEVILLE,  IL  60106
Applicant Contact CAROL SHORT
Correspondent
KONE INSTRUMENTS, INC.
1110 W. THRONDALE AVE.
BENSEVILLE,  IL  60106
Correspondent Contact CAROL SHORT
Regulation Number862.2170
Classification Product Code
JJF  
Date Received02/26/1987
Decision Date 03/13/1987
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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