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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K821560
Device Name LEVEL II LIPID CONTROL
Applicant
Irvine Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Irvine Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/25/1982
Decision Date 07/13/1982
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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