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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipoprotein, Low-Density, Antigen, Antiserum, Control
510(k) Number K994110
Device Name LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
Applicant
Diasorin/American Standard Companies
9175 Guilford Rd.., Suite 100
Quarry Park Pl.
Columbia,  MD  21046
Applicant Contact JUDITH J SMITH
Correspondent
Diasorin/American Standard Companies
9175 Guilford Rd.., Suite 100
Quarry Park Pl.
Columbia,  MD  21046
Correspondent Contact JUDITH J SMITH
Regulation Number866.5600
Classification Product Code
DFC  
Date Received12/06/1999
Decision Date 12/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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