FDA 510(k) Applications Submitted by KHOA TRAN

FDA 510(k) Number Submission Date Device Name Applicant
K141143 05/02/2014 COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET Roche Diagnostics
K221765 06/17/2022 ONLINE DAT Benzodiazepines II Roche Diagnostics
K191899 07/16/2019 Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions Roche Diagnostics
K132418 08/02/2013 COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 Roche Diagnostics
K173857 12/20/2017 Elecsys Tacrolimus Roche Diagnostics


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