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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 K945718
Device Name DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET
Applicant
Casco Standards
P.O Box 970
Yarmouth,  ME  04096
Applicant Contact CHRISTINE V BEACH
Correspondent
Casco Standards
P.O Box 970
Yarmouth,  ME  04096
Correspondent Contact CHRISTINE V BEACH
Regulation Number862.1660
Classification Product Code
JJX  
Date Received11/21/1994
Decision Date 01/17/1995
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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