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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Acetaminophen
510(k) Number K897118
Device Name SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM
Applicant
Medisense, Inc.
128 Sidney St.
Cambridge,  MA  02139
Applicant Contact LIAS, PH.D.
Correspondent
Medisense, Inc.
128 Sidney St.
Cambridge,  MA  02139
Correspondent Contact LIAS, PH.D.
Regulation Number862.3030
Classification Product Code
LDP  
Date Received12/26/1989
Decision Date 05/10/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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