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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 K862202
Device Name VISION(TM) HEMOGLOBIN
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Applicant Contact MATT KLAMRZYNSKI
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact MATT KLAMRZYNSKI
Regulation Number864.7500
Classification Product Code
KHG  
Date Received06/10/1986
Decision Date 08/18/1986
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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