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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 3 of 3 Results
510(K) Number: K162606
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Product Description
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cobas e 801 immunoassay analyzer 2 05/02/2019 Roche Diagnostics Corporation
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, soft... 2 06/10/2018 Roche Diagnostics Corporation
AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR An... 2 10/04/2019 Roche Diagnostics Operations, Inc.