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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 K883861
Device Name DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST
Applicant
Casco Standards
P.O. Box 970
Yarmouth,  ME  04096 -1970
Applicant Contact THOMAS M HAPPE
Correspondent
Casco Standards
P.O. Box 970
Yarmouth,  ME  04096 -1970
Correspondent Contact THOMAS M HAPPE
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/13/1988
Decision Date 10/13/1988
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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