Gen-Probe Pace System Urine Screen
FDA 510(k) K892216 · Gen-Probe, Inc.
510(k) numberK892216
Submission
- Device name
- Gen-Probe Pace System Urine Screen
- Applicant
- Gen-Probe, Inc.
San Diego, CA, US - Received
- April 3, 1989
- Decision date
- September 15, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JXA – Kit, Screening, Urine
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JXA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011043 | Osmetech Microbial Analyser-Urinary Tract Infection Detector (Oma-Uti)JXA · Traditional | Osmetech | 11/30/2001SE |
| K981084 | UriscreenJXA · Traditional | Diatech Diagnostics,Inc. | 10/07/1998SE |
| K972676 | Urine Screening DeviceJXA · Traditional | Combact Diagnostic Systems , Ltd. | 02/23/1998SE |
| K952246 | Tri-Techin. Custom Blood And/Or Urine Transport KitJXA · Traditional | Tri-Tech, Inc. | 06/20/1995SE |
| K950257 | Multiple (Izon DBS & Urine Collection Kit)JXA · Traditional | Izon Business Products, Inc. | 04/14/1995SE |
| K950246 | Multiple (Izon Urine Collection Kit)JXA · Traditional | Izon Business Products, Inc. | 03/21/1995SESK |
| K950221 | Multiple (Izon Blood & Urine Collection Kit)JXA · Traditional | Izon Business Products, Inc. | 03/21/1995SEKD |
| K934759 | Culturia Macconkey-MugJXA · Traditional | Clinical Convenience Products, Inc. | 09/09/1994SE |
| K924218 | Bac-T-ScreenJXA · Traditional | Biomerieux Vitek, Inc. | 02/03/1993SE |
| K921045 | Diaslide Urine Culturing DeviceJXA · Traditional | Savyon Diagnostics , Ltd. | 09/28/1992SE |
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| 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 Pace System Urine Screen cleared by the FDA?
Gen-Probe Pace System Urine Screen (K892216) received a 510(k) decision of Substantially Equivalent on September 15, 1989, 165 days after the submission was received.
What is the product code of K892216?
The FDA product code is JXA – Kit, Screening, Urine, a Class I (low risk) device regulated under 21 CFR 866.2660.