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510(k) K073640

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS by Axis-Shield Diagnostics, Ltd. — Product Code LPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2008
Date Received
December 26, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinary Homocystine (Nonquantitative) Test System
Device Class
Class II
Regulation Number
862.1377
Review Panel
CH
Submission Type

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  • K063701 — TECO HOMOCYSTEINE ENZYMATIC ASSAY (April 11, 2007)
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