Multitrans Culture Collection and Transport System
FDA 510(k) K962843 · Starplex Scientific, Inc.
510(k) numberK962843
Submission
- Device name
- Multitrans Culture Collection and Transport System
- Applicant
- Starplex Scientific, Inc.
Etobicoke, Ontario, CA - Received
- July 22, 1996
- Decision date
- September 18, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JSM – Culture Media, Non-Propagating Transport
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2390
- Specialty
- Microbiology
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| K242976 | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport DeviceJSM · Traditional | Medical Wire & Equipment Company (Bath), Ltd. | 11/26/2025SE |
| K250205 | Babio® Virus Transport Kit (Non-inactivating)JSM · Traditional | Jinan Babio Biotechnology Co., Ltd. | 09/22/2025SE |
| K242576 | AllTest Viral Transport MediumJSM · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 04/04/2025SE |
| K232565 | UriSpongeJSM · Traditional | Copan Italia Spa | 10/11/2024SE |
| K220908 | Ensol EnTM Specimen Collection and Transport SystemJSM · Traditional | Ensol Biosciences, Inc. | 08/29/2024SE |
| K240235 | OmniTrans Transport SystemJSM · Traditional | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 08/19/2024SE |
| K233534 | Viral Transport MediumJSM · Traditional | Hardy Diagnostics | 08/02/2024SE |
| K233449 | Avantik VTMJSM · Traditional | Hanchang Medic Co., Ltd. (Han Chang Medic) | 07/15/2024SE |
| K232454 | Viral Transport Media (VTM)JSM · Traditional | Alb Luz | 05/03/2024SE |
| K232357 | Copan Universal Transport Medium (UTM-RT) SystemJSM · Traditional | Copan Italia Spa | 04/25/2024SE |
More from Copan Italia Spa
| 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 |
| 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 |
| 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 Multitrans Culture Collection and Transport System cleared by the FDA?
Multitrans Culture Collection and Transport System (K962843) received a 510(k) decision of Substantially Equivalent on September 18, 1996, 58 days after the submission was received.
What is the product code of K962843?
The FDA product code is JSM – Culture Media, Non-Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.