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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k063024 B. Purpose for Submission:
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Document Date: 2008-06-24 16:33:18

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File Size: 41,33 KB

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Company

OraSure / Lin-Zhi International Inc. / Hitachi / /

IndustryTerm

collection device / predicate devices / chemical method / stock solution / secondary stock solution / Gas chromatography/mass spectrometry / predicate device / /

MedicalCondition

MS / /

Position

calibrator / drug-free calibrator / Salivette collector / cutoff calibrator / /

Technology

Gas chromatography / /

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