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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 K953221
Device Name ABBOTT VISION HEMOGLOBIN (MODIFICATION)
Applicant
Abbott Laboratories
Dept 49c, Bldg. Ap31
200 Abbott Rd.
Abbott Park,  IL  60064
Applicant Contact GREG LEMIEUX
Correspondent
Abbott Laboratories
Dept 49c, Bldg. Ap31
200 Abbott Rd.
Abbott Park,  IL  60064
Correspondent Contact GREG LEMIEUX
Regulation Number864.7500
Classification Product Code
KHG  
Date Received06/19/1995
Decision Date 09/29/1995
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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