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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, Micro, For Clinical Use
510(k) Number K790197
Device Name REAGENT KIT, LANCER GLUCOSE
Applicant
Sherwood Medical Industries
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sherwood Medical Industries
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2170
Classification Product Code
JJF  
Date Received01/25/1979
Decision Date 03/12/1979
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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