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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K852747
Device Name VISIDEX II REAGENT STRIPS
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
Date Received06/27/1985
Decision Date 08/12/1985
Decision Substantially Equivalent (SESE)
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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