Cleared Traditional

Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

K212193 · Plasmapp Co,., Ltd. · General Hospital
Oct 2021
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K212193 is an FDA 510(k) clearance for the Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40), a Indicator, Biological Sterilization Process (Class II — Special Controls, product code FRC), submitted by Plasmapp Co,., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on October 22, 2021, 100 days after receiving the submission on July 14, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K212193 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2021
Decision Date October 22, 2021
Days to Decision 100 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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