← FDA Medical Device Classifications
Kit, Assay, Progesterone Receptor
LPI · Class III — High Risk (PMA approval required, life-sustaining) · Hematology · 21 CFR 864.1860
Classification
- FDA Product Code
LPI- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 864.1860
- Review panel
- CH
- Medical specialty
- Hematology
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown