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510(k) Data Aggregation
(83 days)
MICRO-STRIP FOR OPIATE METABOLITES
The Microdiagnostics, Inc. Micro-Strip for Opiate Metabolites is intended to qualitatively detect the metabolites of Opiate and Opiate-like drugs in urine.
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The provided document is an FDA 510(k) clearance letter for the "Micro-Strip for Opiate Metabolites" device. It does not contain information about acceptance criteria, device performance studies, or the specifics of such studies. Therefore, I cannot generate the requested table and answer the questions based on the given text.
The document primarily states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing. It outlines regulatory classifications, contact information for further inquiries, and general responsibilities under the Federal Food, Drug, and Cosmetic Act.
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