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FDA 510(k) Applications Submitted by ROCHE DIAGNOSTICS CORPORATION
FDA 510(k) Number
Submission Date
Device Name
Applicant
K141929
07/16/2014
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
ROCHE DIAGNOSTICS CORPORATION
K142089
08/01/2014
ACCU-CHEK AVIVA EXPERT SYSTEM
ROCHE DIAGNOSTICS CORPORATION
K133862
12/19/2013
ACCU-CHEK AVIVA PLUS SYSTEM
ROCHE DIAGNOSTICS CORPORATION
K112528
08/31/2011
ELECSYS T4 CALCHECK 5
ROCHE DIAGNOSTICS CORPORATION
K070172
01/18/2007
AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
ROCHE DIAGNOSTICS CORPORATION
K070174
01/18/2007
AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY
ROCHE DIAGNOSTICS CORPORATION
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