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510(k) K023889

WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 by Wiener Laboratories Saic — Product Code MIU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2004
Date Received
November 21, 2002
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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