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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Surrogate
510(k) Number K880654
Device Name AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200
Applicant
American Research Products Co.
30175 Solon Industrial Pkwy.
P.O. Box 39098
Solon,  OH  44139
Applicant Contact JAN BROWNLEE
Correspondent
American Research Products Co.
30175 Solon Industrial Pkwy.
P.O. Box 39098
Solon,  OH  44139
Correspondent Contact JAN BROWNLEE
Regulation Number862.1150
Classification Product Code
JIW  
Date Received02/17/1988
Decision Date 06/07/1988
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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