CVT Viral Transports
FDA 510(k) K830250 · Immulok, Inc.
510(k) numberK830250
Submission
- Device name
- CVT Viral Transports
- Applicant
- Immulok, Inc.
Mchenry, IL, US - Received
- January 25, 1983
- Decision date
- February 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTW – System, Transport, Aerobic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
Other 510(k)s with product code JTW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121039 | Copan Mswab Collection, Transport and Preservation SystemJTW · Traditional | Copan Flock Technologies | 05/25/2012SE |
| K061301 | Copan Liquid Amies Elution Swab (Eswab) Collection and Transport SystemJTW · Traditional | Copan Diagnostics, Inc. | 06/23/2006SE |
| K022874 | Gen-Probe Aptima Combo 2 AssayJTW · Traditional | Gen-Probe, Inc. | 09/17/2002SE |
| K013819 | Urine Collection, Preservation and Transport SystemJTW · Traditional | Sierra Diagnostic, LLC | 02/28/2002SE |
| K993161 | Copan Easy-Swab Collection and Transport SystemJTW · Traditional | Copan Diagnostics, Inc. | 11/09/1999SE |
| K983244 | Sensititre 18-24 HR Susceptibility Plates(Addition of Meropenem)JTW · Traditional | Trek Diagnostic Systems, Inc. | 11/30/1998SE |
| K961148 | Cefepime Dispans-O-Disc (Cefeplime - 30MCG)JTW · Traditional | Difco Laboratories, Inc. | 04/26/1996SE |
| K934894 | Cultureswab Transport SystemJTW · Traditional | Difco Laboratories, Inc. | 02/22/1994SE |
| K904773 | P and T MediumJTW · Traditional | Gibson Laboratories, Inc. | 12/04/1990SE |
| K895187 | FDL, Inc.'s Transport SystemJTW · Traditional | Fairleigh Dickinson Laboratories, Inc. | 10/24/1989SE |
More from Fairleigh Dickinson Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830971 | Herpes Simplex Virus Typing ReagentsGQL · Traditional | 06/30/1983SE |
| K830342 | Culuture Set Chlamydia Isolation andLKI · Traditional | 05/04/1983SE |
| K823304 | Riaset Prolactin Ria KitCFT · Traditional | 12/22/1982SE |
| K822785 | Fluoroset Immunofluorescent AntibodyGQL · Traditional | 11/29/1982SE |
| K823055 | Flouroset Immunofluorescent AntibodyDHN · Traditional | 11/05/1982SE |
| K822606 | Cytomegalovirus Antobody IggLIN · Traditional | 11/01/1982SE |
| K822605 | Toxoplasma Gondii Antibody IggLJK · Traditional | 10/27/1982SE |
| K822607 | Antinuclear Antobody Cell SubstrateDHN · Traditional | 09/17/1982SE |
| K821567 | Immulok CulturesetGQL · Traditional | 06/25/1982SE |
| K821411 | Histoset Immunoperofidase TissueGQL · Traditional | 06/25/1982SE |
Questions and answers
When was CVT Viral Transports cleared by the FDA?
CVT Viral Transports (K830250) received a 510(k) decision of Substantially Equivalent on February 28, 1983, 34 days after the submission was received.
What is the product code of K830250?
The FDA product code is JTW – System, Transport, Aerobic, a Class I (low risk) device regulated under 21 CFR 866.2900.