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510(k) Data Aggregation
(57 days)
Intended for the In Vitro, quantitative determination of alkaline phosphatase in human serum on automated chemistry analyzers.
Alkaline phosphatase measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
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This document is a 510(k) premarket notification from the FDA, which confirms that a medical device (JAS Alkaline Phosphatase Liquid Reagent) is substantially equivalent to existing devices. It does not contain the detailed study information regarding acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment that you've requested.
Therefore, I cannot fulfill your request using the provided text. The document is essentially an approval letter, not a scientific study report.
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(10 days)
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