Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BioSci™ Disposable Virus Sampling Tubes

K-Number: K230035 · 2023-04-05

ApplicantShenzhen Dakewe Bio-Engineering Co., Ltd.
Decision Date2023-04-05
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BioSci™ Disposable Virus Sampling Tubes is a medical device manufactured by Shenzhen Dakewe Bio-Engineering Co., Ltd.. It received FDA 510(k) clearance on 2023-04-05 under approval number K230035. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioSci™ Disposable Virus Sampling Tubes?

BioSci™ Disposable Virus Sampling Tubes is a medical device that received FDA 510(k) clearance on 2023-04-05. It is manufactured by Shenzhen Dakewe Bio-Engineering Co., Ltd.. The 510(k) number is K230035.

When was BioSci™ Disposable Virus Sampling Tubes approved by the FDA?

BioSci™ Disposable Virus Sampling Tubes received FDA 510(k) clearance on 2023-04-05, under approval number K230035.

What company makes BioSci™ Disposable Virus Sampling Tubes?

BioSci™ Disposable Virus Sampling Tubes is manufactured by Shenzhen Dakewe Bio-Engineering Co., Ltd..

What is the FDA product code for BioSci™ Disposable Virus Sampling Tubes?

The FDA product code for BioSci™ Disposable Virus Sampling Tubes is JSM.

Related Clinical Trials

NCT07355400 Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances RECRUITING

Other Devices by Shenzhen Dakewe Bio-Engineering Co., Ltd.

K220059Biosci™ Inactivated Transport Medium, Biosci™ ITM K240235OmniTrans Transport System

Related Devices (Code: JSM)

K162284Puritan Fecal Opti-Swab Collection and Transport SystemPuritan Medical Products, LLC K160082Puritan Opti-Tranz Cary-Blair Collection and Transport SystemPuritan Medical Products, LLC K163436Greiner Vacuette Urine Count and Culture, Mannitol tubeGreiner Bio-One Na, Inc. K180052UriSwab-Urine Collection, Transport and Preservation SystemCopan Italia Spa K201674Cultura Collection and Transport SystemMerit Medical Systems, Inc. K220052Copan FecalSwab Collection, Transport and Preservation SystemCopan Italia Spa

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑