BD MAX CT/GC/TV, BD MAX INSTRUMENT— 510(k) K151589
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K151589 for BD MAX CT/GC/TV, BD MAX INSTRUMENT, Substantially Equivalent on 2016-09-06. Applicant: Becton, Dickinson and Company. Device class: 2.
Clearance details
- Applicant
- Becton, Dickinson and Company
- Product code
- Code OUY
- Device class
- Class 2
- Regulation
- 21 CFR 866.3860
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
Recent devices under product code OUY
view all- K231316 — Aptima Trichomonas vaginalis Assay
- K182692 — BD MAX CTGCTV2, BD MAX System
- K161619 — Xpert 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 Systems
- K161182 — Solana Trichomonas Assay
- K151565 — Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit
More clearances from Becton, Dickinson and Company
view all- K260128 — BD Preset and BD A-Line Arterial Blood Collection Syringes
- K252378 — BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube
- K252506 — BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder
- K260184 — Onclarity Self-Collection Kit
- K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
Recalls naming K151589
K-number listed on FDA's recall record- Z-2331-2019 — Kit BD Max CT/GC/TV; Catalog # 442970
- Z-0394-2018 — BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151589.
Data sourced from openFDA. This site is unofficial and independent of the FDA.