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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinary Homocystine (Nonquantitative) Test System
510(k) Number K992858
Device Name ABBOTT AXSYM HOMOCYSTEINE
Applicant
Abbott Laboratories
Dept 9yc, Bidg. Ap31
200 Abbott Park Rd.
Abbott Park,  IL  60064 -6200
Applicant Contact MARGARET PROCHNIAK
Correspondent
Abbott Laboratories
Dept 9yc, Bidg. Ap31
200 Abbott Park Rd.
Abbott Park,  IL  60064 -6200
Correspondent Contact MARGARET PROCHNIAK
Regulation Number862.1377
Classification Product Code
LPS  
Date Received08/25/1999
Decision Date 10/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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