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510(k) Data Aggregation
(49 days)
VANCOMYCIN EIA ASSAY
The Vancomycin Enzyme Immunoassay is intended for in vitro diagnostic use for quantitative determination of vancomycin in human serum or plasma.
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The provided text is a 510(k) premarket notification approval letter for the Vancomycin Enzyme Immunoassay. It does not contain information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the 510(k) submission document itself, not in the FDA's approval letter.
Therefore, I cannot fulfill your request with the given input. The document is solely an approval stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
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