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SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT

Focus Diagnostics, Inc. · Class I · Cleared Apr 4, 2012

K-numberK113433
Device nameSIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
ApplicantFocus Diagnostics, Inc.
Product codeOMN
Device classClass I
Decision dateApr 4, 2012
DecisionSubstantially Equivalent
Regulation866.2660
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View the full FDA submission: accessdata.fda.gov

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