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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator/Data Processing Module, For Clinical Use
510(k) Number K842401
Device Name CHEMISTRY CONSOLE
Applicant
BIOVATION, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIOVATION, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.2100
Classification Product Code
JQP  
Date Received06/19/1984
Decision Date 09/04/1984
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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