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The provided text is a 510(k) premarket notification letter from the FDA for a device called "PS-UNIT CASSETTE/Serum and Urine Combo HCG Test" (later referred to as "One Step Serum / urine Combo HCG Cassette Test"). It does not contain information about acceptance criteria, device performance, or a study proving its conformance to such criteria. The letter primarily confirms that the FDA has determined the device to be substantially equivalent to devices marketed prior to May 28, 1976.

Therefore, I cannot extract the requested information as it is not present in the provided document.

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