← FDA Medical Device Classifications
Instrument, Hematocrit, Automated
GKF · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.5600
Classification
- FDA Product Code
GKF- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 864.5600
- Review panel
- HE
- Medical specialty
- Hematology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 15
- Registered establishments
- 21
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown