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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 K945315
Device Name DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL
Applicant
CASCO STANDARDS
500 RIVERSIDE INDUSTRIAL PARK
PORTLAND,  ME  04103
Correspondent
CASCO STANDARDS
500 RIVERSIDE INDUSTRIAL PARK
PORTLAND,  ME  04103
Regulation Number862.1660
Classification Product Code
JJY  
Date Received11/01/1994
Decision Date 12/09/1994
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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