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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K843947
Device Name DOUMENT TM LINEARITY TEST STANDARDS
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
JIX  
Date Received10/09/1984
Decision Date 10/17/1984
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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