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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K892238
Device Name CLA 200 CHEMPRO(R) LIPID ANALYZER
Applicant
Johnson & Johnson Professionals, Inc.
2675 Long Lake Rd.
Roseville,  MN  55113
Applicant Contact PETER J CORDON
Correspondent
Johnson & Johnson Professionals, Inc.
2675 Long Lake Rd.
Roseville,  MN  55113
Correspondent Contact PETER J CORDON
Regulation Number862.1175
Classification Product Code
CHH  
Date Received04/04/1989
Decision Date 06/07/1989
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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