Tag: Hybritech Tandem R PSA Test Kit
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The Second FDA approved PSA Test
Hybritech was determined to get its PSA test approved by the FDA for expanded uses; rather than continuing to have physicians to use the test…
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How Did the First Prostate Specific Antigen (PSA) Test get FDA Approval
For medical devices (Class I and II), to gain FDA approval, the device must be deemed SAFE and EFFECTIVE. This is done via a 510(K)-approval…