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510(k) K141929

ACCU-CHEK CONNECT DIABETES MANAGEMENT APP by Roche Diagnostics Corporation — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2015
Date Received
July 16, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Drug Dose
Device Class
Class II
Regulation Number
868.1890
Review Panel
CH
Submission Type

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  • K070174 — AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCE (April 16, 2007)

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