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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flame Emission Photometer For Clinical Use
510(k) Number K841847
Device Name LITHIUM REAGENT
Applicant
Reagent Laboratory, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Reagent Laboratory, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2540
Classification Product Code
JJO  
Date Received04/18/1984
Decision Date 08/17/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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