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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Purple Dye-Binding, Albumin
510(k) Number K862138
Device Name VISION ALBUMIN
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact MATT KLAMRZYNSKI
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact MATT KLAMRZYNSKI
Regulation Number862.1035
Classification Product Code
CJW  
Date Received06/04/1986
Decision Date 06/17/1986
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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