Cleared Traditional

TROPHON CHEMICAL INDICATOR

K103126 · Nanosonics Limited · General Hospital
Mar 2011
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K103126 is an FDA 510(k) clearance for the TROPHON CHEMICAL INDICATOR, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Nanosonics Limited (Alexandria, Nsw, AU). The FDA issued a Cleared decision on March 3, 2011, 132 days after receiving the submission on October 22, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K103126 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2010
Decision Date March 03, 2011
Days to Decision 132 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code JOJ — Indicator, Physical/chemical Sterilization Process
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2800

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