Search Results

This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of Lactate dehydrogenase in serum or leomonogram in the for in vitro diagnostic use only. The determination of Lactate dehydrogenase in serum is most commonly performed for the diagnosis and treatment of myocardial infarctions. LD elevations are also observed in liver disease, pernicious anemia, some cases of renal disease, and in cases of skeletal muscle trauma.

Liquid LDH-L Reagent Set

The provided text is a 510(k) premarket notification letter from the FDA regarding a "Liquid LDH-L Reagent Kit." This document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a 510(k) summary.

Therefore, I cannot extract the information required to populate the table and answer the questions. The letter only confirms that the device is substantially equivalent to a predicate device and can be marketed. It refers to "indications for use stated in the enclosure," but the enclosure itself is a simple "Indications for Use" statement and does not contain the requested study details.

To answer your request, I would need a different document, such as the 510(k) summary or the full submission, which would detail the studies performed to demonstrate substantial equivalence.

Ask a specific question about this device