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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipase-Esterase, Enzymatic, Photometric, Lipase
510(k) Number K900827
Device Name COLORIMETRIC CHLORIDE PRODUCT #4314125
Applicant
American Research Products Co.
30175 Solon Industrial Pkwy.
P.O. Box 39098
Solon,  OH  44139
Applicant Contact C. K OWENS
Correspondent
American Research Products Co.
30175 Solon Industrial Pkwy.
P.O. Box 39098
Solon,  OH  44139
Correspondent Contact C. K OWENS
Regulation Number862.1465
Classification Product Code
CHI  
Date Received02/21/1990
Decision Date 05/02/1990
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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