Quantra
FDA 510(k) clearance K163623 · decided 2017-10-20
Clearance details
- K-number
- K163623
- Device name
- Quantra
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-12-22
- Decision date
- 2017-10-20
- Days to decision
- 302 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Danbury, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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| Aptima HBV Quant Assay (P170025/S022) | Hologic, Inc. | 2024-10-23 |