← FDA Medical Device Classifications
Beta 2-Microglobulin Apheresis Column
PDI · f · Unknown
Classification
- FDA Product Code
PDI- 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
Relief of symptoms of clinically diagnosed dialysis-related amyloidosis (DRA).
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown