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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Refractometer For Clinical Use
510(k) Number K811342
Device Name REAGENT STRIPS FOR URINALYSIS
Applicant
Miles Laboratories, Inc.
1127 Myrtle St.
P.O. Box 40
Elkhart,  IN  46514
Correspondent
Miles Laboratories, Inc.
1127 Myrtle St.
P.O. Box 40
Elkhart,  IN  46514
Regulation Number862.2800
Classification Product Code
JRE  
Date Received05/12/1981
Decision Date 09/01/1981
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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