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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Phenolphthalein Colorimetry, Carbon-Dioxide
510(k) Number K870025
Device Name AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS
Applicant
American Research Products Co.
30175 Solon Industrial Pkwy.
P.O. Box 39098
Solon,  OH  44139
Applicant Contact TIMOTHY J BELCASTRO
Correspondent
American Research Products Co.
30175 Solon Industrial Pkwy.
P.O. Box 39098
Solon,  OH  44139
Correspondent Contact TIMOTHY J BELCASTRO
Regulation Number862.1160
Classification Product Code
KMS  
Date Received01/05/1987
Decision Date 03/13/1987
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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