510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k091612 - substantial equivalence - Document - PDFSEARCH.IO

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	510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k091612 Add to Reading List Document Date: 2010-03-04 13:00:10 Open Document File Size: 83,48 KB Share Result on Facebook Company UPC BioSciences Inc. / IgG / AMP / / IndustryTerm operators/site / alternate chemical method / test device / point-of-care site / Gas chromatography/mass spectrometry / visually-read single-use device / predicate device / / Product sodium chloride / Acetaminophen / / Technology 3-D / Gas chromatography / antibodies / Drug Screening / in vitro diagnostics / / SocialTag Pharmacology Anorectics Stimulants Dopamine agonists Monoamine oxidase inhibitors Drug test Cocaine Buprenorphine Urinalysis Chemistry

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k091612Add to Reading List