FDA 510(k) Applications Submitted by David Tribbett

FDA 510(k) Number Submission Date Device Name Applicant
K140373 02/14/2014 ISE INDIRECT NA, K, C1 FOR GEN 2 Roche Diagnostics
K160571 02/29/2016 cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay Roche Diagnostics Operations (RDO)
K151578 06/11/2015 Carbamazepine Gen 4 Roche Diagnostics Operations (RDO)
K123726 12/04/2012 COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 Roche Diagnostics


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