Tri-Tech Inc. Custom Sexual Assault Kit
FDA 510(k) K922343 · Tri-Tech, Inc.
510(k) numberK922343
Submission
- Device name
- Tri-Tech Inc. Custom Sexual Assault Kit
- Applicant
- Tri-Tech, Inc.
Durham, NC, US - Received
- May 19, 1992
- Decision date
- February 17, 1994
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 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 |
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| 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 |
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| 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 |
|---|---|---|
| K971111 | Tri-Tech Inc., Evacuated Blood Collection Tube, Gray StopperJKA · Traditional | 06/16/1997SE |
| K952246 | Tri-Techin. Custom Blood And/Or Urine Transport KitJXA · Traditional | 06/20/1995SE |
| K922342 | Tri-Tech Inc. Custom Blood AlcoholJKA · Traditional | 08/27/1993SEKD |
| K912140 | Stairmaster Model 6000 ErgometerISD · Traditional | 12/17/1991SE |
| K912058 | Gauntlet Stair ClimberISD · Traditional | 10/24/1991SE |
| K912057 | 4000 PT Exercise SystemISD · Traditional | 10/24/1991SE |
| K912056 | Gravitron Upper Body System ExerciserISD · Traditional | 10/24/1991SE |
| K900983 | Tri-Tech Urine Specimen KitFMH · Traditional | 09/17/1990SE |
| K843839 | Stat/Pb ReagentDOF · Traditional | 01/03/1985SE |
| K813075 | Tritec Doc TMBZD · Traditional | 12/09/1981SE |
Questions and answers
When was Tri-Tech Inc. Custom Sexual Assault Kit cleared by the FDA?
Tri-Tech Inc. Custom Sexual Assault Kit (K922343) received a 510(k) decision of Unknown on February 17, 1994, 639 days after the submission was received.
What is the product code of K922343?
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.