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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Selective (Non-Specified)
510(k) Number K860143
Device Name URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE
Applicant
Reagent Laboratory, Inc.
300 E. Ottawa Ave.
Louisville,  KY  40209
Applicant Contact DON SKAGGS
Correspondent
Reagent Laboratory, Inc.
300 E. Ottawa Ave.
Louisville,  KY  40209
Correspondent Contact DON SKAGGS
Regulation Number862.2050
Classification Product Code
JJP  
Date Received01/15/1986
Decision Date 02/10/1986
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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