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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Cpk Or Isoenzymes
510(k) Number K860663
Device Name AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT
Applicant
Amresco, Inc.
30175 Solon Industrial Pkwy.
Solon,  OH  44139
Applicant Contact TIMOTHY J BELCASTRO
Correspondent
Amresco, Inc.
30175 Solon Industrial Pkwy.
Solon,  OH  44139
Correspondent Contact TIMOTHY J BELCASTRO
Regulation Number862.1215
Classification Product Code
JHY  
Date Received02/24/1986
Decision Date 04/11/1986
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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