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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K093955
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Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM... 2 01/29/2019 FEI # 1823260
Roche Diagnostics Corporation
Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A v... 2 12/12/2019 FEI # 1823260
Roche Diagnostics Operations, Inc.
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