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510(k) K945538

STAPHAUREX PLUS(TM) by Murex Diagnostics Limitd — Product Code JWX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1995
Date Received
November 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Screening, Staphylococcus Aureus
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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