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The Waters 2487 Dual Wavelength Detector is designed for the routine Quality Assurance/Quality Control laboratory as well as possessing features which would meet methods development and R&D requirements. Waters believes this detector will be utilized in both large and small facilities where high reliability, ease of training, start-up and operation, and design efficiency are important. These facilities may include Universities, industrial and pharmaceutical facilities, manufacturing facilities, analytical laboratories and hospitals. The product is not intended exclusively for clinical use. In using this product, the operator must follow generally accepted procedures for quality control and methods development.

Waters® 2487 Tunable Dual Wavelenqth Absorbance Dectector

I apologize, but the provided text from the FDA letter (K973074 and K9935074) for the Waters® 2487 Tunable Dual Wavelength Absorbance Detector does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a 510(k) clearance letter, which states that the device is "substantially equivalent" to predicate devices already marketed. It does not detail the technical performance criteria, clinical trial results, or specific metrics of the device's accuracy, sensitivity, or specificity.

Therefore, I cannot populate the table or answer the specific questions you've asked based on the provided text. To answer your questions, I would need a detailed study report, a performance characteristics document, or a similar technical assessment that includes the design of the study, the performance metrics, and the acceptance criteria.

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