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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K910962
Device Name CHOLESTEROL CALIBRATOR SET
Applicant
Casco Standards
P.O Box 970
Yarmouth,  ME  04096
Applicant Contact THOMAS M HAPPE
Correspondent
Casco Standards
P.O Box 970
Yarmouth,  ME  04096
Correspondent Contact THOMAS M HAPPE
Regulation Number862.1150
Classification Product Code
JIT  
Date Received03/06/1991
Decision Date 03/29/1991
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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