Extended Lipid Panel Assay
FDA 510(k) clearance K181373 · decided 2018-10-18
Clearance details
- K-number
- K181373
- Device name
- Extended Lipid Panel Assay
- Applicant
- Laboratory Corporation of America Holdings
- Decision
- Substantially Equivalent
- Date received
- 2018-05-24
- Decision date
- 2018-10-18
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- CHH
- Device class
- 1
- Regulation number
- 862.1175
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Morrisville, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.