Cleared Traditional

Self-Contained Biological Indicator

K200970 · True Indicating, LLC · General Hospital
Dec 2020
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K200970 is an FDA 510(k) clearance for the Self-Contained Biological Indicator, a Indicator, Biological Sterilization Process (Class II — Special Controls, product code FRC), submitted by True Indicating, LLC (Toledo, US). The FDA issued a Cleared decision on December 28, 2020, 259 days after receiving the submission on April 13, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K200970 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2020
Decision Date December 28, 2020
Days to Decision 259 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRC — Indicator, Biological Sterilization Process
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2800

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