FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
C. ALBICANS PNA FISH
K Number: K092655
·
Decision Jan 19, 2010
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
21
Review Days
144
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Basic Information
- Device Name
- C. ALBICANS PNA FISH
- K Number
- K092655
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Advandx, Inc.
- Date Received
- August 28, 2009
- Decision Date
- January 19, 2010
- Product Code
- NZS
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NZS | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NZS), ordered by most recent decision date.
YEAST TRAFFIC LIGHT PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
C. ALBICANS/C. GLABRATA PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Advandx, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K140619 | MECA XPRESSFISH | Oct 10, 2014 | Substantially Equivalent |
| K123418 | GRAM-NEGATIVE QUICKFISH BC | Jul 21, 2013 | Substantially Equivalent |
| K121991 | ENTEROCOCCUS QUICKFISH BC | Jan 7, 2013 | Substantially Equivalent |
| K113371 | STAPHYLOCOCCUS QUICKFISH BC | Apr 3, 2012 | Substantially Equivalent |
| K101558 | GNR TRAFFIC LIGHT PNA FISH | Dec 16, 2010 | Substantially Equivalent |
| K093024 | YEAST TRAFFIC LIGHT PNA FISH | Jul 15, 2010 | Substantially Equivalent |
| K092784 | C. ALBICANS/C. GLABRATA PNA FISH | Mar 12, 2010 | Substantially Equivalent |
| K092236 | E.COLI/P. AERUGINOSA PNA FISH | Dec 16, 2009 | Substantially Equivalent |
| K092166 | S. AUREUS/CNS PNA FISH, MODEL KT005 | Nov 23, 2009 | Substantially Equivalent |
| K092393 | EK/P. AERUGINOSA PNA FISH | Sep 1, 2009 | Substantially Equivalent |