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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Green Dye-Binding, Albumin
510(k) Number K792482
Device Name CHEMISTRY ANALYZER REAGENTS
Applicant
Laboratory Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Laboratory Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1035
Classification Product Code
CIX  
Date Received11/19/1979
Decision Date 01/11/1980
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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