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Roche Diagnostics Operations

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K241220 Tina-quant Lipoprotein(a) Gen.2 MolarityDFC2025-01-24 View
510(k) K233454 ONLINE TDM MethotrexateLAO2024-02-20 View
510(k) K163633 cobas HbA1c Test, cobas b 101 systemLCP2017-07-28 View
510(k) K121610 COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAYPDJ2013-08-08 View
510(k) K113072 TINA-QUANT ALBUMIN GEN.2DCF2012-05-14 View
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