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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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