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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrolyte Controls (Assayed And Unassayed)
510(k) Number K912513
Device Name ELECTROLYTE CONTROL
Applicant
Verichem Laboratories, Inc.
90 Narragansett Ave.
Providence,  RI  02907
Applicant Contact ANTHONY J DIMONTE
Correspondent
Verichem Laboratories, Inc.
90 Narragansett Ave.
Providence,  RI  02907
Correspondent Contact ANTHONY J DIMONTE
Regulation Number862.1660
Classification Product Code
JJR  
Date Received06/06/1991
Decision Date 07/19/1991
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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