Vacuplus Tubes with Lavander Stoppers
FDA 510(k) K924362 · Starplex Scientific, Inc.
510(k) numberK924362
Submission
- Device name
- Vacuplus Tubes with Lavander 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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More from Sol-Millennium Medical, Inc.
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| 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 |
| K924364 | Vacuplus Tubes with Grey 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 Lavander Stoppers cleared by the FDA?
Vacuplus Tubes with Lavander Stoppers (K924362) 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 K924362?
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.