Cultureswab Transport System
FDA 510(k) K934894 · Difco Laboratories, Inc.
510(k) numberK934894
Submission
- Device name
- Cultureswab Transport System
- Applicant
- Difco Laboratories, Inc.
Detroit, MI, US - Received
- October 5, 1993
- Decision date
- February 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JTW – System, Transport, Aerobic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
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|---|---|---|---|
| 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 |
| 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 |
| K882580 | Mechanical Change in In-Vitro Micro DeviceJTW · Traditional | Precision Dynamics Corp. | 07/08/1988SE |
More from Precision Dynamics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K971211 | Dispens-O-Disc SparfloxacinJTN · Traditional | 04/14/1997SE |
| K971120 | Dispens-O-Disc (TM) LevofloxacinJTN · Traditional | 04/14/1997SE |
| K963508 | Dispens-O-Disc MeropenemJTN · Traditional | 09/26/1996SE |
| K961148 | Cefepime Dispans-O-Disc (Cefeplime - 30MCG)JTW · Traditional | 04/26/1996SE |
| K954783 | Dryslide CartarrhalisJTO · Traditional | 02/06/1996SE |
| K954784 | Dryside NeisseriaLTS · Traditional | 01/30/1996SE |
| K953129 | Esp Culture System - MycoMDB · Traditional | 12/26/1995SE |
| K950706 | Dryslide CoagulaseJTL · Traditional | 05/16/1995SE |
| K944275 | Dispens-O-Disc Piperacillin 100 Mcg./Tazobactam 10 Mcg.JTN · Traditional | 12/19/1994SE |
| K941016 | Dispens-O-Disc(Tm) NitrocefinJTO · Traditional | 06/30/1994SE |
Questions and answers
When was Cultureswab Transport System cleared by the FDA?
Cultureswab Transport System (K934894) received a 510(k) decision of Substantially Equivalent on February 22, 1994, 140 days after the submission was received.
What is the product code of K934894?
The FDA product code is JTW – System, Transport, Aerobic, a Class I (low risk) device regulated under 21 CFR 866.2900.