E.Coli/P. Aeruginosa Pna Fish
FDA 510(k) K092236 · Advandx, Inc.
510(k) numberK092236
Submission
- Device name
- E.Coli/P. Aeruginosa Pna Fish
- Applicant
- Advandx, Inc.
Woburn, MA, US - Received
- July 23, 2009
- Decision date
- December 16, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JSS – Kit, Identification, Enterobacteriaceae
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code JSS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150031 | hemoFISH MasterpanelJSS · Traditional | Miacom Diagnostics GmbH | 10/01/2015SE |
| K123418 | Gram-Negative Quickfish BCJSS · Traditional | Advandx, Inc. | 07/21/2013SE |
| K101558 | GNR Traffic Light Pna FishJSS · Traditional | Advandx, Inc. | 12/16/2010SE |
| K092393 | Ek/P. Aeruginosa Pna FishJSS · Traditional | Advandx, Inc. | 09/01/2009SE |
| K082068 | E. Coli Pna FishJSS · Traditional | Advandx, Inc. | 06/25/2009SE |
| K081433 | Ek/P. Aeruginosa Pna FishJSS · Traditional | Advandx, Inc. | 03/26/2009SE |
| K081309 | E.Coli/P. Aeruginosa Pna FishJSS · Traditional | Advandx, Inc. | 12/19/2008SE |
| K926002 | Alamar Bacterial Identification Test PanelJSS · Traditional | Alamar Biosciences Laboratory, Inc. | 09/23/1993SE |
| K926018 | Crystal Enteric/Nonfermenter Id SystemJSS · Traditional | Becton Dickinson Microbiology Systems | 03/11/1993SE |
| K926017 | Crystal Rapid Stool/Enteric Id SystemJSS · Traditional | Becton Dickinson Microbiology Systems | 03/11/1993SE |
More from Becton Dickinson Microbiology Systems
| 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 |
| K092166 | S. Aureus/Cns Pna Fish, Model KT005NXX · Traditional | 11/23/2009SE |
| K092393 | Ek/P. Aeruginosa Pna FishJSS · Traditional | 09/01/2009SE |
Questions and answers
When was E.Coli/P. Aeruginosa Pna Fish cleared by the FDA?
E.Coli/P. Aeruginosa Pna Fish (K092236) received a 510(k) decision of Substantially Equivalent on December 16, 2009, 146 days after the submission was received.
What is the product code of K092236?
The FDA product code is JSS – Kit, Identification, Enterobacteriaceae, a Class I (low risk) device regulated under 21 CFR 866.2660.