POMC/PCSK1/LEPR CDx Panel
FDA 510(k) clearance DEN200059 · decided 2022-01-21
Clearance details
- K-number
- DEN200059
- Device name
- POMC/PCSK1/LEPR CDx Panel
- Applicant
- Preventiongenetics, LLC
- Decision
- Unknown
- Date received
- 2020-09-18
- Decision date
- 2022-01-21
- Days to decision
- 490 days
- Clearance type
- Direct
- Product code
- QRV
- Device class
- 2
- Regulation number
- 862.1164
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Marshfield, WI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Preventiongenetics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.