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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coulometric, Chloride
510(k) Number K811319
Device Name CHLORIDE REAGENT KIT
Applicant
Chem-Elec, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Chem-Elec, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1170
Classification Product Code
JFS  
Date Received05/12/1981
Decision Date 08/13/1981
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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