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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride
510(k) Number K870214
Device Name MODIFIED SALTEX 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
Regulation Number862.1170
Classification Product Code
CHK  
Date Received01/20/1987
Decision Date 06/29/1987
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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