Sudormed Sweat Patch Specimen Container for Collection of Amphetamines in Perspiration
FDA 510(k) K935588 · Sudormed, Inc.
510(k) numberK935588
Submission
- Device name
- Sudormed Sweat Patch Specimen Container for Collection of Amphetamines in Perspiration
- Applicant
- Sudormed, Inc.
Santa Ana, CA, US - Received
- November 17, 1993
- Decision date
- July 14, 1995
- Decision
- Substantially Equivalent (SESE)
- 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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| 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 |
|---|---|---|
| K936135 | Sudormed Sweat Patch Specimen Container for Collection of Marijuana in PerspirationLAT · Traditional | 06/10/1996SE |
| K936240 | Sudormed Sweat Patch Speciment Container (Phencyclidine)JKA · Traditional | 03/19/1996SE |
| K935564 | Sudormed Sweat Patch Specimen Container for Collection of Opiates in PerspirationJKA · Traditional | 07/14/1995SE |
| K926253 | Sudormed Sweat Patch Specimen Container: CocaineJKA · Traditional | 07/14/1995SE |
| K902442 | Sudormed Sweat Patch Specimen ContainerJKA · Traditional | 10/04/1990SE |
Questions and answers
When was Sudormed Sweat Patch Specimen Container for Collection of Amphetamines in Perspiration cleared by the FDA?
Sudormed Sweat Patch Specimen Container for Collection of Amphetamines in Perspiration (K935588) received a 510(k) decision of Substantially Equivalent on July 14, 1995, 604 days after the submission was received.
What is the product code of K935588?
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.