Cleared Special

ACCU-CHEK ULTRFLEX INFUSION SET

K101196 · Roche Diagnostics Corp. · General Hospital
Aug 2010
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K101196 is an FDA 510(k) clearance for the ACCU-CHEK ULTRFLEX INFUSION SET, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on August 27, 2010, 120 days after receiving the submission on April 29, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K101196 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2010
Decision Date August 27, 2010
Days to Decision 120 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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