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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 K861778
Device Name CLINIFACTS 200 DATA MANAGEMENT SYSTEM
Applicant
MILES LABORATORIES, INC.
1127 MYRTLE ST.
P.O. BOX 40
ELKHART,  IN  46514
Applicant Contact JOHN H ENGELMANN
Correspondent
MILES LABORATORIES, INC.
1127 MYRTLE ST.
P.O. BOX 40
ELKHART,  IN  46514
Correspondent Contact JOHN H ENGELMANN
Regulation Number862.2100
Classification Product Code
JQP  
Date Received05/08/1986
Decision Date 07/02/1986
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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