Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)— 510(k) DEN220042

Name: FDA 510(k) clearance DEN220042
Creator: U.S. Food and Drug Administration
Published: 2024-07-12

Unknown

Terragene S.A.

FDA 510(k) clearance DEN220042 for Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH), Unknown on 2024-07-12. Applicant: Terragene S.A.. Device class: 2.

Clearance details

Applicant: Terragene S.A.
Product code: Code QVB
Device class: Class 2
Regulation: 21 CFR 880.2806
Advisory panel: General Hospital
Date received: 2022-07-01
Decision date: 2024-07-12
Decision: Unknown
Clearance type: Direct
Location: Alvear, AR

View on FDA.gov ↗

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K232103 — Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)2024-04-05
K221641 — Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)2023-02-28
K200272 — Terragene Chemdye2020-06-30

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