Gen-Probe Aptima Combo 2 Assay
FDA 510(k) K022874 · Gen-Probe, Inc.
510(k) numberK022874
Submission
- Device name
- Gen-Probe Aptima Combo 2 Assay
- Applicant
- Gen-Probe, Inc.
San Diego, CA, US - Received
- July 26, 2002
- Decision date
- September 17, 2002
- 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
Other 510(k)s with product code JTW
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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 |
| 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 |
| K882580 | Mechanical Change in In-Vitro Micro DeviceJTW · Traditional | Precision Dynamics Corp. | 07/08/1988SE |
More from Precision Dynamics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K122062 | Aptima Trichomonas Vaginalis Assay - PantherOUY · Traditional | 01/09/2013SE |
| K111409 | Aptima Combo 2 AssayLSL · Traditional | 05/03/2012SE |
| K063664 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae MODEL#1091LSL · Traditional | 01/25/2007SE |
| K063451 | Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1199MKZ · Traditional | 01/22/2007SE |
| K062440 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091LSL · Traditional | 11/07/2006SE |
| K061413 | Aptima CT Assay on the Tigris DTS SystemMKZ · Traditional | 10/13/2006SE |
| K061509 | Tigris DTS Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1196LSL · Traditional | 10/04/2006SE |
| K060652 | Tigris DTS Gen-Probe Aptima Combo 2 AssayLSL · Traditional | 08/17/2006SE |
| K053446 | Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1088MKZ · Traditional | 07/25/2006SE |
| K043224 | Gen-Probe Aptima Combo 2 AssayLSL · Traditional | 08/09/2005SE |
Questions and answers
When was Gen-Probe Aptima Combo 2 Assay cleared by the FDA?
Gen-Probe Aptima Combo 2 Assay (K022874) received a 510(k) decision of Substantially Equivalent on September 17, 2002, 53 days after the submission was received.
What is the product code of K022874?
The FDA product code is JTW – System, Transport, Aerobic, a Class I (low risk) device regulated under 21 CFR 866.2900.