AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
FDA 510(k) clearance K083074 · decided 2009-07-24
Clearance details
- K-number
- K083074
- Device name
- AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
- Applicant
- Advandx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-15
- Decision date
- 2009-07-24
- Days to decision
- 282 days
- Clearance type
- Traditional
- Product code
- OAH
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Woburn, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ENTEROCOCCUS QUICKFISH BC (K121991) | Advandx, Inc. | 2013-01-07 |
| GBS PNA FISH (K082612) | Advandx, Inc. | 2009-05-05 |
| ENTEROCOCCUS FAECALIS PNA FISH (K063127) | Advandx, Inc. | 2006-12-22 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multic recall (Z-2315-2010) | AdvanDx, Inc. | 2010-08-31 |