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FDA 510(k) Applications Submitted by Roche Diagnostics GmbH
FDA 510(k) Number
Submission Date
Device Name
Applicant
K143446
12/02/2014
Accu-Chek FlexLink Plus infusion set
Roche Diagnostics GmbH
K981281
04/08/1998
ELECSYS CALCHECK FERRITIN
ROCHE DIAGNOSTICS GMBH
K981278
04/08/1998
ELECSYS CALCHECK CA 125II
ROCHE DIAGNOSTICS GMBH
K981282
04/08/1998
ELECSYS AFP
ROCHE DIAGNOSTICS GMBH
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