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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
510(k) Number K833157
Device Name LANCER ANALYZER CUPS
Applicant
Sherwood Medical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sherwood Medical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2150
Classification Product Code
JJC  
Date Received09/16/1983
Decision Date 12/08/1983
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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