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FDA 510(k) Applications Submitted by Lisa K. Klinedinst
FDA 510(k) Number
Submission Date
Device Name
Applicant
K131544
05/29/2013
COBAS C BILIRUBIN TOTAL GEN.3
Roche Diagnostics
K122722
09/05/2012
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
Roche Diagnostics
K113521
11/29/2011
CALCIUM GEN. 2
Roche Diagnostics
K170938
03/30/2017
CalSet IGF-1
Roche Diagnostics
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