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Roche Diagnostics GmbH

5 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Elecsys Calcitonin (K252431)Roche Diagnostics GmbH2026-04-24
Accu-Chek FlexLink Plus infusion set (K143446)Roche Diagnostics GmbH2015-08-13
ELECSYS AFP (K981282)Roche Diagnostics GmbH1998-05-01
ELECSYS CALCHECK FERRITIN (K981281)Roche Diagnostics GmbH1998-04-24
ELECSYS CALCHECK CA 125II (K981278)Roche Diagnostics GmbH1998-04-23

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Every clearance here is in the API, with alerts when new ones post.