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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Whole Blood Hemoglobin Determination
510(k) Number K822044
Device Name SERALYZER HEMOGLOBIN REAGENT STRIPS
Applicant
MILES LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MILES LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.7500
Classification Product Code
KHG  
Date Received07/12/1982
Decision Date 07/30/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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