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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 K940568
Device Name DOCUMENT(R) ZERO
Applicant
Casco Standards
P.O Box 970
Yarmouth,  ME  04096
Applicant Contact LENITY LARRABEE
Correspondent
Casco Standards
P.O Box 970
Yarmouth,  ME  04096
Correspondent Contact LENITY LARRABEE
Regulation Number862.1660
Classification Product Code
JJX  
Date Received02/08/1994
Decision Date 04/05/1994
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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