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

FDA 510(k)

BD CTGCTV2

K-Number: K243343 · 2025-04-22

ApplicantBd Integrated Diagnostic Solutions/Becton,
Decision Date2025-04-22
Product CodeQEP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD CTGCTV2 is the device name listed in this FDA 510(k) record. The listed applicant is Bd Integrated Diagnostic Solutions/Becton,. It received FDA 510(k) clearance on 2025-04-22 under 510(k) number K243343. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD CTGCTV2?

BD CTGCTV2 is a medical device that received FDA 510(k) clearance on 2025-04-22. The listed applicant is Bd Integrated Diagnostic Solutions/Becton,. The 510(k) number is K243343.

When did BD CTGCTV2 receive FDA 510(k) clearance?

BD CTGCTV2 received FDA 510(k) clearance on 2025-04-22, under 510(k) number K243343.

Who is the listed applicant for BD CTGCTV2?

The FDA 510(k) record lists Bd Integrated Diagnostic Solutions/Becton, as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD CTGCTV2?

The FDA product code for BD CTGCTV2 is QEP.

Related Devices (Code: QEP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systemsRoche Molecular Systems, Inc.K253759cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.K253756cobas liat CT/NG nucleic acid testRoche Molecular Systems, Inc.K251501Visby Medical Men's Sexual Health TestVisby Medical, Inc.K240217cobas® liat CT/NG nucleic acid testRoche Molecular Systems, Inc.K240197cobas® liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.

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.

↑