510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K112228 - substantial equivalence - Document - PDFSEARCH.IO

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	510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K112228 Add to Reading List Document Date: 2011-12-22 12:16:52 Open Document File Size: 113,42 KB Share Result on Facebook City Reading / / Company VITEK 2 Compact Systems / bioMerieux Inc. / Streptococci 2 / VITEK 2 Systems / / Event FDA Phase / / IndustryTerm culture media / detection algorithm / study site / external site / microbiological culture media / predicate device / / MedicalCondition recommended Streptococcus pneumonia QC / / Organization FDA / / Product Levofloxacin / Amoxicillin / K112228 / M7-A8 / Streptococcus Levofloxacin / / ProvinceOrState California / / Technology detection algorithm / pdf / test organism Instrument Test Card Item Test Method Antibiotic Reading algorithm / / URL http / SocialTag Biology Streptococcaceae Gram-positive bacteria Levofloxacin Epsilometer test Streptococcus Norfloxacin Ofloxacin Minimum inhibitory concentration Bacteria

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K112228Add to Reading List