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510(k) K072732

ORTHO T. CRUZI ELISA TEST SYSTEM by Ortho-Clinical Diagnostics, Inc. — Product Code MIU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2009
Date Received
September 26, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunosorbent Assay, T. Cruzi
Device Class
Class I
Regulation Number
866.3870
Review Panel
MI
Submission Type

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