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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, primary
510(k) Number K843110
Device Name ROCHE STANDARDS FOR CHOLESTEROL
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ROCHE DIAGNOSTIC SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1150
Classification Product Code
JIS  
Date Received08/07/1984
Decision Date 09/04/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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