Kultsure (Culture Transport)
FDA 510(k) K860178 · Ncs Diagnostics, Inc.
510(k) numberK860178
Submission
- Device name
- Kultsure (Culture Transport)
- Applicant
- Ncs Diagnostics, Inc.
Mississauga, L4z 1y6, CA - Received
- January 17, 1986
- Decision date
- April 4, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSM – Culture Media, Non-Propagating Transport
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2390
- Specialty
- Microbiology
Other 510(k)s with product code JSM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K943499 | Kultsure STARSWAB(M240), ModificationJSM · Traditional | 11/30/1994SE |
| K943498 | Kultsure Starswab (M210), ModificationJSM · Traditional | 11/30/1994SE |
| K882811 | StrepslideGTY · Traditional | 10/25/1988SE |
| K881209 | Aso Slide TestGTQ · Traditional | 04/12/1988SE |
| K874019 | StaphslideJWX · Traditional | 10/28/1987SE |
| K871404 | KultsureJSM · Traditional | 04/21/1987SE |
| K870231 | KultsureLIO · Traditional | 02/04/1987SE |
| K860655 | Kultsure (Catalogue No. M200)LIO · Traditional | 03/06/1986SE |
| K860658 | Kultsure (Catalogue No. M250)JSM · Traditional | 03/04/1986SE |
| K860657 | Kultsure (Catalogue No. M240)JSM · Traditional | 03/04/1986SE |
Questions and answers
When was Kultsure (Culture Transport) cleared by the FDA?
Kultsure (Culture Transport) (K860178) received a 510(k) decision of Substantially Equivalent on April 4, 1986, 77 days after the submission was received.
What is the product code of K860178?
The FDA product code is JSM – Culture Media, Non-Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.