Biosci Inactivated Transport Medium, Biosci ITM— 510(k) K220059

Name: FDA 510(k) clearance K220059
Creator: U.S. Food and Drug Administration
Published: 2023-01-19

Substantially Equivalent

Shenzhen Dakewe Bio-Engineering Co., Ltd.

FDA 510(k) clearance K220059 for Biosci Inactivated Transport Medium, Biosci ITM, Substantially Equivalent on 2023-01-19. Applicant: Shenzhen Dakewe Bio-Engineering Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Dakewe Bio-Engineering Co., Ltd.
Product code: Code QBD
Device class: Class 2
Regulation: 21 CFR 866.2950
Advisory panel: Microbiology
Date received: 2022-01-10
Decision date: 2023-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code QBD

view all

K242820 — Puritan PurSafe Plus Collection and Transport System2025-05-27
K240797 — PPH Saliva Collection Kit2024-10-11
K222771 — Sample Preservative Fluid2024-06-26
K233324 — Molecular Transport Media - MTM2024-06-17
K221547 — InActiv Blue2024-06-11

More clearances from Shenzhen Dakewe Bio-Engineering Co., Ltd.

view all

K240235 — OmniTrans Transport System2024-08-19
K230035 — BioSci Disposable Virus Sampling Tubes2023-04-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.