Cleared Traditional

Terragene? Bionova? Hyper Biological Indicator (BT98), Terragene? Bionova? Hyper Auto-reader Incubator (BHY), Terragene? Bionova? NanoBio Auto-reader Incubator (BNB)

K221641 · Terragene S.A. · General Hospital
Feb 2023
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K221641 is an FDA 510(k) clearance for the Terragene? Bionova? Hyper Biological Indicator (BT98), Terragene? Bionova? Hyper Auto-reader Incubator (BHY), Terragene? Bionova? NanoBio Auto-reader Incubator (BNB), a Indicator, Biological Sterilization Process (Class II — Special Controls, product code FRC), submitted by Terragene S.A. (Alvear, AR). The FDA issued a Cleared decision on February 28, 2023, 267 days after receiving the submission on June 6, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K221641 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2022
Decision Date February 28, 2023
Days to Decision 267 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

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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