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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 K802264
Device Name WASH SOLUTION KIT, #88102
Applicant
Hi Chem, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hi Chem, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2170
Classification Product Code
JJF  
Date Received09/16/1980
Decision Date 10/31/1980
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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