Cleared Traditional

Rapicide PA High-Level Disinfectant Test Strips

K152394 · Medivators, Inc. · General Hospital
Mar 2016
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K152394 is an FDA 510(k) clearance for the Rapicide PA High-Level Disinfectant Test Strips, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Medivators, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 11, 2016, 200 days after receiving the submission on August 24, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K152394 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2015
Decision Date March 11, 2016
Days to Decision 200 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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