Cleared Abbreviated

Gas-Chex Indicator

K212592 · Propper Manufacturing Co., Inc. · General Hospital
Jan 2022
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K212592 is an FDA 510(k) clearance for the Gas-Chex Indicator, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Propper Manufacturing Co., Inc. (Long Island, US). The FDA issued a Cleared decision on January 20, 2022, 157 days after receiving the submission on August 16, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K212592 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2021
Decision Date January 20, 2022
Days to Decision 157 days
Submission Type Abbreviated
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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