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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 K982003
Device Name DS30 HCY HOMOCYSTEINE ASSAY KIT
Applicant
Drew Scientific , Ltd.
Park Rd.,Telemeter Bldg.
Barrow In Furness,  GB LA 14 4QR
Applicant Contact ANDREW KENNEY
Correspondent
Drew Scientific , Ltd.
Park Rd.,Telemeter Bldg.
Barrow In Furness,  GB LA 14 4QR
Correspondent Contact ANDREW KENNEY
Regulation Number862.1377
Classification Product Code
LPS  
Date Received06/08/1998
Decision Date 02/11/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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