VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
FDA 510(k) clearance K140083 · decided 2014-06-20
Clearance details
- K-number
- K140083
- Device name
- VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
- Applicant
- Nanosphere, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-01-13
- Decision date
- 2014-06-20
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- PCH
- Device class
- 2
- Regulation number
- 866.3990
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Northbrook, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 recall (Z-2023-2023) | Luminex Corporation | 2023-06-28 |
| The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test f recall (Z-2685-2014) | Nanosphere, Inc. | 2014-09-23 |