C. ALBICANS PNA FISH
FDA 510(k) clearance K092655 · decided 2010-01-19
Clearance details
- K-number
- K092655
- Device name
- C. ALBICANS PNA FISH
- Applicant
- Advandx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-08-28
- Decision date
- 2010-01-19
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- NZS
- Device class
- 1
- Regulation number
- 866.2660
- 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 |
|---|---|---|
| YEAST TRAFFIC LIGHT PNA FISH (K093024) | Advandx, Inc. | 2010-07-15 |
| C. ALBICANS/C. GLABRATA PNA FISH (K092784) | Advandx, Inc. | 2010-03-12 |
Recalls involving this device
No recalls on record reference this clearance.