Search Results

Gambro DryAC acid concentrate mix for bicarbonate hemodialysis is indicated for use with concentrated bicarbonate solution in 3-stream proportioning artificial kidney equipment using purified, AAMI standard water.

Gambro DryAC is an acid concentrate mix used for the preparation of acid dialysis concentrate solutions that are used in bicarbonate hemodialysis.

The provided text does not contain information about acceptance criteria, device performance,
or studies with human readers or AI.

The document is a 510(k) premarket notification summary for a medical device called "DryAC Acid Concentrate Mix for Bicarbonate Hemodialysis." It establishes substantial equivalence to a predicate device, focusing on chemical composition, intended use, and lack of significant technological changes. There is no mention of a study involving human readers, AI, or specific performance metrics that would require acceptance criteria.

Therefore, I cannot fulfill the request to provide the acceptance criteria and study details based on the provided input.

Ask a specific question about this device