FDA 510(k)

BD CTGCTV2

Numéro K : K243343 · 2025-04-22

DemandeurBd Integrated Diagnostic Solutions/Becton,

Date de décision2025-04-22

Code produitQEP

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositifs connexes (Code : QEP)

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.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.