GBS PNA FISH
FDA 510(k) clearance K082612 · decided 2009-05-05
Clearance details
- K-number
- K082612
- Device name
- GBS PNA FISH
- Applicant
- Advandx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-09
- Decision date
- 2009-05-05
- Days to decision
- 238 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 |
| AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT (K083074) | Advandx, Inc. | 2009-07-24 |
| ENTEROCOCCUS FAECALIS PNA FISH (K063127) | Advandx, Inc. | 2006-12-22 |
Recalls involving this device
No recalls on record reference this clearance.