BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE— 510(k) K023075
Substantially EquivalentBd Vacutainer Systems Preanalyical Solutions
FDA 510(k) clearance K023075 for BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE, Substantially Equivalent on 2002-11-25. Applicant: Bd Vacutainer Systems Preanalyical Solutions. Device class: 2.
Clearance details
- Applicant
- Bd Vacutainer Systems Preanalyical Solutions
- Product code
- Code JKA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lakes, NJ, US
Recent devices under product code JKA
view all- K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
- 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
- K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
More clearances from Bd Vacutainer Systems Preanalyical Solutions
view allAdverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K023075
K-number listed on FDA's recall record- Z-2055-2018 — BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983
- Z-2056-2018 — BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023075.
Data sourced from openFDA. This site is unofficial and independent of the FDA.