Vacuplus Tubes with Grey Stoppers
FDA 510(k) K924364 · Starplex Scientific, Inc.
510(k) numberK924364
Submission
- Device name
- Vacuplus Tubes with Grey Stoppers
- Applicant
- Starplex Scientific, Inc.
Etobicoke, Ontario, CA - Received
- August 28, 1992
- Decision date
- March 1, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
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| K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access DeviceJKA · Traditional | Zhejiang Kindly Medical Device Co., Ltd. | 06/02/2026SE |
| K260128 | BD Preset and BD A-Line Arterial Blood Collection SyringesJKA · Special | Becton, Dickinson and Company | 04/15/2026SE |
| K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood…JKA · Traditional | Becton, Dickinson and Company | 04/10/2026SE |
| K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood…JKA · Traditional | Becton, Dickinson and Company | 04/10/2026SE |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood…JKA · Traditional | Becton, Dickinson and Company | 03/13/2026SE |
| K251812 | Steripath® Flow Blood Collection SystemJKA · Traditional | Magnolia Medical Technologies | 09/25/2025SE |
| K243207 | BD Vacutainer® Eclipse Blood Collection NeedleJKA · Traditional | Becton, Dickinson and Company | 07/03/2025SE |
| K250961 | Blood collection tube holdersJKA · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 06/04/2025SE |
| K244047 | Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)JKA · Traditional | Venocare, Inc. | 05/23/2025SE |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetJKA · Special | Sol-Millennium Medical, Inc. | 04/30/2025SE |
More from Sol-Millennium Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K032246 | Modification to Multitrans Culture Collection and Transport SystemJSM · Special | 08/13/2003SE |
| K022388 | Startox Drug of Abuse Screening Test (4)DJC · Traditional | 02/27/2003SE |
| K021006 | Startox Drug of Abuse Screening TestDKZ · Traditional | 06/10/2002SE |
| K962843 | Multitrans Culture Collection and Transport SystemJSM · Traditional | 09/18/1996SE |
| K960997 | Starswab Culture Collection and Transport SystemLIO · Traditional | 04/03/1996SE |
| K944847 | Kultsure/Starswab Anaerobic Transport SystemJSL · Traditional | 02/16/1995SE |
| K924362 | Vacuplus Tubes with Lavander StoppersJKA · Traditional | 03/01/1993SE |
| K924361 | Vacuplus Tubes with Green StoppersJKA · Traditional | 03/01/1993SE |
| K924363 | Vacuplus(R) Star-Sep(Tm)JKA · Traditional | 02/08/1993SE |
| K924365 | Vacuplus Tubes with Brick Red StoppersJKA · Traditional | 12/28/1992SE |
Questions and answers
When was Vacuplus Tubes with Grey Stoppers cleared by the FDA?
Vacuplus Tubes with Grey Stoppers (K924364) received a 510(k) decision of Substantially Equivalent on March 1, 1993, 185 days after the submission was received.
What is the product code of K924364?
The FDA product code is JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection, a Class II (moderate risk) device regulated under 21 CFR 862.1675.