C. Albicans Pna Fish
FDA 510(k) K092655 · Advandx, Inc.
510(k) numberK092655
Submission
- Device name
- C. Albicans Pna Fish
- Applicant
- Advandx, Inc.
Woburn, MA, US - Received
- August 28, 2009
- Decision date
- January 19, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NZS – Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast.
Other 510(k)s with product code NZS
More from Advandx, Inc.
| 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 |
| K092236 | E.Coli/P. Aeruginosa Pna FishJSS · Traditional | 12/16/2009SE |
| 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 C. Albicans Pna Fish cleared by the FDA?
C. Albicans Pna Fish (K092655) received a 510(k) decision of Substantially Equivalent on January 19, 2010, 144 days after the submission was received.
What is the product code of K092655?
The FDA product code is NZS – Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast, a Class I (low risk) device regulated under 21 CFR 866.2660.