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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K893140
Device Name DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET
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
JJX  
Date Received04/25/1989
Decision Date 06/23/1989
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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