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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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