NMR LIPOPROFILE (R) TEST AND NMR PROFILER
FDA 510(k) clearance K111516 · decided 2011-09-27
Clearance details
- K-number
- K111516
- Device name
- NMR LIPOPROFILE (R) TEST AND NMR PROFILER
- Applicant
- Liposcience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-01
- Decision date
- 2011-09-27
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- LBS
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Raleigh, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.