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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION CHECKLIST
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Document Date: 2009-03-04 13:03:45

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File Size: 309,37 KB

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Company

NOVX Systems Inc. / /

Event

FDA Phase / /

Facility

Laboratory Use L. Test Principle / /

IndustryTerm

alternate chemical method / calibrator solutions / predicate devices / stock solution / in vitro diagnostic device / stop solution / substrate solution / clinical chemistry devices / /

Position

physician / calibrator / Clinical toxicology calibrator / /

Product

EP12-A / /

Technology

Spectroscopy / EP12-A User protocol / Gas Chromatography / antibodies / /

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