Yeast Traffic Light Pna Fish
FDA 510(k) K080719 · Advandx, Inc.
510(k) numberK080719
Submission
- Device name
- Yeast Traffic Light Pna Fish
- Applicant
- Advandx, Inc.
Woburn, MA, US - Received
- March 13, 2008
- Decision date
- September 12, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JXB – Kit, Identification, Yeast
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JXB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K062461 | C. Albicans Pna FishJXB · Traditional | Advandx, Inc. | 10/25/2006SE |
| K993554 | YeastestJXB · Traditional | Diagnostic Markers, Inc. | 02/10/2000SE |
| K943621 | Rapid Yeast Plus SystemJXB · Traditional | Innovative Diagnostic Systems, Inc. | 01/27/1995SE |
| K935124 | Bacticard CandidaJXB · Traditional | Remel Co. | 02/25/1994SE |
| K900112 | Microring YtJXB · Traditional | Medical Wire & Equipment Co. | 07/31/1990SE |
| K881925 | Vitek Yeast Biochemical CardJXB · Traditional | Vitek Systems, Inc. | 06/16/1988SE |
| K860575 | Yeast Identification PanelJXB · Traditional | American Micro Scan | 05/13/1986SE |
| K830286 | Yeast IdentJXB · Traditional | Analytical Products, Inc. | 04/05/1983SE |
| K802309 | MS-2 Identification SystemJXB · Traditional | Abbott Laboratories | 12/01/1980SE |
| K800803 | Nitrate Swab-Rapid TestJXB · Traditional | Remel Co. | 07/08/1980SE |
More from Remel Co.
| 510(k) | Device | Decision |
|---|---|---|
| K140619 | Meca XpressfishMYI · Traditional | 10/10/2014SE |
| K123418 | Gram-Negative Quickfish BCJSS · Traditional | 07/21/2013SE |
| K121991 | Enterococcus Quickfish BCOAH · Traditional | 01/07/2013SE |
| K113371 | Staphylococcus Quickfish BCNXX · Traditional | 04/03/2012SE |
| K101558 | GNR Traffic Light Pna FishJSS · Traditional | 12/16/2010SE |
| K093024 | Yeast Traffic Light Pna FishNZS · Traditional | 07/15/2010SE |
| K092784 | C. Albicans/C. Glabrata Pna FishNZS · Traditional | 03/12/2010SE |
| K092655 | C. Albicans Pna FishNZS · Traditional | 01/19/2010SE |
| K092236 | E.Coli/P. Aeruginosa Pna FishJSS · Traditional | 12/16/2009SE |
| K092166 | S. Aureus/Cns Pna Fish, Model KT005NXX · Traditional | 11/23/2009SE |
Questions and answers
When was Yeast Traffic Light Pna Fish cleared by the FDA?
Yeast Traffic Light Pna Fish (K080719) received a 510(k) decision of Substantially Equivalent on September 12, 2008, 183 days after the submission was received.
What is the product code of K080719?
The FDA product code is JXB – Kit, Identification, Yeast, a Class I (low risk) device regulated under 21 CFR 866.2660.