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OSOM C. DIFFICILE TOXIN A/B TEST

Genzyme Corporation · Class I · Cleared Dec 21, 2010

K-numberK102242
Device nameOSOM C. DIFFICILE TOXIN A/B TEST
ApplicantGenzyme Corporation
Product codeLLH
Device classClass I
Decision dateDec 21, 2010
DecisionSubstantially Equivalent
Regulation866.2660
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View the full FDA submission: accessdata.fda.gov

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