510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k102210 - substantial equivalence - Document - PDFSEARCH.IO

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	510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k102210 Add to Reading List Document Date: 2011-01-04 12:58:06 Open Document File Size: 161,03 KB Share Result on Facebook Company Lin-Zhi International Inc. / Hitachi / / IndustryTerm chemical method / stock solution / predicate device / / Person Semi-Quantitative Cutoff / Qualitative Enzyme / Semi-Quantitative Enzyme / Semi-Quantitative Method Comparison / Amphetamines Assay Type Same Qualitative / / Position Calibrator Negative Calibrator / calibrator / ng/mL Calibrator / Clinical toxicology calibrator / / Product Sodium Chloride / Valproic Acid / / Technology antibodies / / SocialTag Chemistry Anorectics Immunologic tests Amphetamines Dopamine agonists Immunoassay ELISA Methamphetamine Dextroamphetamine Medicine

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k102210Add to Reading List