510(k) K220908
- Device
- Ensol EnTM Specimen Collection and Transport System
- Applicant
- Ensol Biosciences, Inc.
- 510(k) number
- K220908
- Product code
- JSM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-29
- Date received
- 2022-03-29
- Regulation
- 866.2390
- Classification name
- Culture Media, Non-Propagating Transport
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Cheol-Min Lee
- Address
- 51, Techno 10-Ro, Yuseong-Gu Daejeon KR 34036 34036
FDA Registration Numbers#
- 3016587486
- 9681576
- 3017830316
- 1720929
- 3009963993
- 3009732568
- 3015173212
- 3018779125
- 3006198300
- 3000268902
- 2183744
- 1063851
- 3043127647
- 3013188547
- 3018348
- 1220477
- 3009613136
- 9681465
- 2013736
- 3014150341
- 3011649813
- 1043646
- 3017170972
- 2436875
- 1524213
- 3024463179
- 1318354
- 3014588186
- 3016741564
- 3016838963
- 3005739529
- 1216735
- 1924669
- 3010131578
- 3001124136
- 3017063217
- 1917413
- 2243072
- 2022807
- 3009302820
- 3003207991
- 3012073813
- 3015441043
- 3002444944
- 3010600155
- 9617475
- 3005182159
- 9610649
- 3010132111
- 3015376545
- 8020315
- 3035375122
- 3012389632
- 8020040
- 9613662
- 3008132411
- 3010407203
- 3010420046
- 3014662855
- 3012494290
- 1319639
- 3016837106
- 3013557562
- 3013661582
- 3015505238
- 3017231634
- 9680143
- 3027519599
- 3009547954
- 3004530258
- 3003750284
Source Documents#
Other 510(k) Records For Product Code JSM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242976 | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device | Medical Wire & Equipment Company (Bath), Ltd. | 2025-11-26 |
| K250205 | Babio® Virus Transport Kit (Non-inactivating) | Jinan Babio Biotechnology Co., Ltd. | 2025-09-22 |
| K242576 | AllTest Viral Transport Medium | Hangzhou AllTest Biotech Co., Ltd. | 2025-04-04 |
| K232565 | UriSponge™ | Copan Italia Spa | 2024-10-11 |
| K240235 | OmniTrans Transport System | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2024-08-19 |
| K233534 | Viral Transport Medium | Hardy Diagnostics | 2024-08-02 |
| K233449 | Avantik VTM | Hanchang Medic Co., Ltd. (Han Chang Medic) | 2024-07-15 |
| K232454 | Viral Transport Media (VTM) | Alb Luz | 2024-05-03 |
| K232357 | Copan Universal Transport Medium (UTM-RT) System | Copan Italia Spa | 2024-04-25 |
| K202531 | Azer Scientific Universal Transport Medium | Azer Scientific, Inc. | 2024-04-11 |
| K231843 | ARX Viral Transport Media Collection and Transport System | Arx Sciences, Inc. | 2024-03-19 |
| K231027 | KaiBiLi Extended ViralTrans | Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | 2023-12-21 |
| K212743 | MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System | Medschenker, Inc. | 2023-05-03 |
| K230035 | BioSci™ Disposable Virus Sampling Tubes | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2023-04-05 |
| K220052 | Copan FecalSwab Collection, Transport and Preservation System | Copan Italia Spa | 2022-12-16 |