S. AUREUS PNA FISH
FDA 510(k) clearance K060099 · decided 2006-05-08
Clearance details
- K-number
- K060099
- Device name
- S. AUREUS PNA FISH
- Applicant
- Advandx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-01-13
- Decision date
- 2006-05-08
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- NXX
- Device class
- 1
- Regulation number
- 866.3700
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Canton, 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 |
|---|---|---|
| STAPHYLOCOCCUS QUICKFISH BC (K113371) | Advandx, Inc. | 2012-04-03 |
| S. AUREUS/CNS PNA FISH, MODEL KT005 (K092166) | Advandx, Inc. | 2009-11-23 |
| S. AUREUS PNA FISH (K091827) | Advandx, Inc. | 2009-08-18 |
Recalls involving this device
No recalls on record reference this clearance.