Culture Collection Device
FDA 510(k) K881105 · Medical Packaging Corp.
510(k) numberK881105
Submission
- Device name
- Culture Collection Device
- Applicant
- Medical Packaging Corp.
Camarillo, CA, US - Received
- March 15, 1988
- Decision date
- April 25, 1988
- 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 |
|---|---|---|
| K003761 | Nat - Nucleic Acid TransportLIO · Traditional | 05/31/2001SE |
| K972726 | Snap Swab Culture Collection and Transport SystemJSM · Traditional | 10/08/1997SE |
| K970597 | Culture-Pak Collection and Transport System with Clinical Transport Media (Cary-Blair…JSM · Traditional | 03/24/1997SE |
| K964637 | Culture Collection and Transport System, Modified Amies MediaJSM · Traditional | 12/24/1996SE |
| K936078 | Culture-Pak Collection/Transport System, ModifiedJSM · Traditional | 08/16/1994SE |
| K932337 | Culture-Pak Collection and Transport SystemJSM · Traditional | 08/16/1994SE |
| K915454 | Chlamydia Trachomatis Specimen Collection KitLIO · Traditional | 04/08/1992SE |
| K870398 | Pap-Pak Cytobrush KitHHT · Traditional | 02/25/1987SE |
| K864323 | Cytology BrushesHHT · Traditional | 01/09/1987SE |
Questions and answers
When was Culture Collection Device cleared by the FDA?
Culture Collection Device (K881105) received a 510(k) decision of Substantially Equivalent on April 25, 1988, 41 days after the submission was received.
What is the product code of K881105?
The FDA product code is JSM – Culture Media, Non-Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.