STAPHYLOCOCCUS QUICKFISH BC
FDA 510(k) clearance K113371 · decided 2012-04-03
Clearance details
- K-number
- K113371
- Device name
- STAPHYLOCOCCUS QUICKFISH BC
- Applicant
- Advandx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-11-16
- Decision date
- 2012-04-03
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- NXX
- Device class
- 1
- Regulation number
- 866.3700
- 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 |
|---|---|---|
| S. AUREUS/CNS PNA FISH, MODEL KT005 (K092166) | Advandx, Inc. | 2009-11-23 |
| S. AUREUS PNA FISH (K091827) | Advandx, Inc. | 2009-08-18 |
| S. AUREUS PNA FISH (K060099) | Advandx, Inc. | 2006-05-08 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. T recall (Z-2138-2014) | Advandx Inc | 2014-08-01 |