510(k) K091292
- Device
- BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771
- Applicant
- BECTON DICKINSON AND COMPANY (BD)
- 510(k) number
- K091292
- Product code
- JKA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-08-25
- Date received
- 2009-05-04
- Regulation
- 862.1675
- Classification name
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY ANN ALSBERGE
- Address
- 1 Becton Dr. Mc 300 Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 3003895930
- 3014662855
- 3008337059
- 3020831613
- 3002637618
- 1933913
- 1063851
- 3008496607
- 3014312726
- 9681835
- 3015309643
- 3009963993
- 3022964615
- 1047843
- 3011689956
- 3014162214
- 3013298431
- 3009889060
- 3004153557
- 3034667025
- 3004425647
- 2028807
- 8041187
- 1226230
- 9680448
- 3044026004
- 3014456066
- 3013517171
- 2032112
- 3005674478
- 3015972753
- 9613662
- 1024879
- 1319639
- 3007616112
- 2648727
- 3013187142
- 2243072
- 1054811
- 3030419987
- 3008733163
- 3004824601
- 1219611
- 8010026
- 3006950086
- 3013652330
- 3043051314
- 3015620563
- 3009518015
- 3004416208
- 3042871620
- 1043214
- 1055927
- 3016884191
- 3012552122
- 3030243919
- 3006850222
- 3012536737
- 3004597845
- 9610847
- 3010531069
- 3020294761
- 9617604
- 9617032
- 3017923561
- 1710034
- 1423537
- 2245437
- 3001124136
- 3027553380
- 3009742443
- 2032098
- 3030896267
- 3010512490
- 3007829657
- 2916714
- 1125230
- 1917413
- 8021764
- 3014570560
Source Documents#
Other 510(k) Records For Product Code JKA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access Device | Zhejiang Kindly Medical Device Co., Ltd. | 2026-06-02 |
| K260128 | BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes | Becton, Dickinson and Company | 2026-04-15 |
| K252378 | BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube | Becton, Dickinson and Company | 2026-04-10 |
| K252506 | BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder | Becton, Dickinson and Company | 2026-04-10 |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes | Becton, Dickinson and Company | 2026-03-13 |
| K251812 | Steripath® Flow™ Blood Collection System | Magnolia Medical Technologies | 2025-09-25 |
| K243207 | BD Vacutainer® Eclipse™ Blood Collection Needle | Becton, Dickinson and Company | 2025-07-03 |
| K250961 | Blood collection tube holders | Promisemed Hangzhou Meditech Co., Ltd. | 2025-06-04 |
| K244047 | Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) | Venocare, Inc. | 2025-05-23 |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | Sol-Millennium Medical, Inc. | 2025-04-30 |
| K243649 | BD Vacutainer® Multiple Sample Luer Adapter | Becton, Dickinson and Company | 2025-03-21 |
| K241586 | PIVO™ Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-02-27 |
| K242320 | BD Vacutainer® One Use Holder | Becton, Dickinson and Company | 2024-11-01 |
| K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. | 2024-07-19 |
| K232781 | Safety Sliding Blood Collection Set | Jiangsu Caina Medical Co.,Ltd | 2024-03-07 |
Legacy Summary#
summary
FDA Review#
Decision Summary