510(k) DEN200059
- Device
- POMC/PCSK1/LEPR CDx Panel
- Applicant
- Preventiongenetics, LLC
- 510(k) number
- DEN200059
- Product code
- QRV
- Decision
- Unknown (DENG)
- Decision date
- 2022-01-21
- Date received
- 2020-09-18
- Regulation
- 862.1164
- Classification name
- Setmelanotide Eligibility Gene Variant Detection System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Jerry Machado
- Address
- 3800 S. Business Park Ave. Marshfield WI US 54449 54449
Source Documents
510(k) summary PDF not indicated by FDA