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The MS 4/5 is a quantitative, automated hematology analyzer that provides a leukocyte differential for in vitro diagnostic use in clinical laboratories.

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The provided texts are from a 510(k) premarket notification for the MS 4/5 Hematology Analyzer, primarily containing the FDA's response and the Indications for Use statement. It does not contain the detailed acceptance criteria and study information that would typically be found in the manufacturer's submission for device performance.

Therefore, I cannot provide the requested information from these documents. To answer your questions, I would need the actual study report or the sections of the 510(k) submission that detail the performance testing and acceptance criteria for the MS 4/5 Hematology Analyzer.

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The MS 9/5 is a quantitative, automated hematology analyzer that provides a leukocyte differential count for In-Vitro diagnostic use in clinical laboratories.

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The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets the acceptance criteria for the MS 9/5 Hematology Analyzer. The document is primarily a 510(k) clearance letter from the FDA, confirming substantial equivalence to a predicate device for marketing purposes. It states the device's indications for use but does not delve into the specific performance study details, acceptance criteria, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given input.

What is available from the text:

• Device Name: MS 9/5 Hematology Analyzer
• Indications for Use: The MS 9/5 is a quantitative, automated hematology analyzer that provides a leukocyte differential count for In-Vitro diagnostic use in clinical laboratories.

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