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 MAX CT/GC/TV, BD MAX INSTRUMENT

K-Number: K151589 · 2016-09-06

ApplicantBecton, Dickinson and Company
Decision Date2016-09-06
Product CodeOUY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BD MAX CT/GC/TV, BD MAX INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K151589. The device is classified under product code OUY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD MAX CT/GC/TV, BD MAX INSTRUMENT?

BD MAX CT/GC/TV, BD MAX INSTRUMENT is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K151589.

When did BD MAX CT/GC/TV, BD MAX INSTRUMENT receive FDA 510(k) clearance?

BD MAX CT/GC/TV, BD MAX INSTRUMENT received FDA 510(k) clearance on 2016-09-06, under 510(k) number K151589.

Who is the listed applicant for BD MAX CT/GC/TV, BD MAX INSTRUMENT?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD MAX CT/GC/TV, BD MAX INSTRUMENT?

The FDA product code for BD MAX CT/GC/TV, BD MAX INSTRUMENT is OUY.

Related Clinical Trials

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.

NCT05957406SMART TRENDS StudyCOMPLETEDNCT06492746Personal BP - CAI StudyRECRUITINGNCT07148323HemoSphere Alta StudyRECRUITINGNCT07216573The Continuity StudyRECRUITINGNCT07317648ClearSight NextGen1 StudyCOMPLETED

Other records listing Becton, Dickinson and Company as applicant

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.

PMA P160037KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUSK260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeK260184Onclarity™ Self-Collection KitK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes

View all 100 devices →

Related Devices (Code: OUY)

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.

K231316Aptima Trichomonas vaginalis AssayHologic, Inc.K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and CompanyK161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 SystemsCepheidK161182Solana Trichomonas AssayQuidel Corporation

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.

↑