← FDA Medical Device Classifications
Plasma Processing System For Converting Alpha To Pre-Beta High-Density Lipoprotein
QNB · f · Unknown
Classification
- FDA Product Code
QNB- Device class
- f
- Regulation
- —
- Review panel
- GU
- Medical specialty
- Unknown
- Submission type
- 6
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
To reduce coronary atheroma in patients with Homozygous Familial Hypercholesterolemia.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown