Preserv Cary Blair Transport Pack
FDA 510(k) K840990 · Preventive Diagnostics Corp.
510(k) numberK840990
Submission
- Device name
- Preserv Cary Blair Transport Pack
- Applicant
- Preventive Diagnostics Corp.
Mchenry, IL, US - Received
- March 7, 1984
- Decision date
- March 23, 1984
- 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 |
|---|---|---|
| K840677 | HDL EZ-TZ3 Cholesterol Reagent KitLBS · Traditional | 04/13/1984SE |
| K840676 | PDC HDL Ez-Sep Cholesterol ReagentLBS · Traditional | 04/04/1984SE |
| K840991 | Preserv Buffered Glycerol SalineJTW · Traditional | 03/23/1984SE |
| K840968 | Preserv Transport & Culture PackJTW · Traditional | 03/23/1984SE |
| K840278 | HDL Cholesterol Controls-LevelsJIX · Traditional | 03/23/1984SE |
| K840220 | HDL Cholesterol Aqueous StandardsJIS · Traditional | 03/23/1984SE |
| K840219 | Triglyceride/Cholesterol AqueousJIX · Traditional | 03/23/1984SE |
| K840218 | Triglyceride Aqueous StandardsJIT · Traditional | 03/23/1984SE |
| K840217 | Cholesterol Aqueous StandardJIS · Traditional | 03/23/1984SE |
| K840189 | Total Cholesterol Reagent SetCHH · Traditional | 03/23/1984SE |
Questions and answers
When was Preserv Cary Blair Transport Pack cleared by the FDA?
Preserv Cary Blair Transport Pack (K840990) received a 510(k) decision of Substantially Equivalent on March 23, 1984, 16 days after the submission was received.
What is the product code of K840990?
The FDA product code is JTW – System, Transport, Aerobic, a Class I (low risk) device regulated under 21 CFR 866.2900.