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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, hemoglobin, automated
510(k) Number K812127
Device Name KING DIAGNOSTICS HEMOGLOBIN TEST
Applicant
KING DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KING DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.5620
Classification Product Code
GKR  
Date Received07/27/1981
Decision Date 08/25/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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