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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 K931139
Device Name DOCULMENT(R) CHEM VI CALIBRATION VERIF 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
JJY  
Date Received03/05/1993
Decision Date 05/12/1993
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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