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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K170548
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InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human ... 2 12/15/2020 Enterix, Inc.
InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack... 2 11/28/2025 Enterix, Inc.
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