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GJE · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1675
Classification
- FDA Product Code
GJE- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 862.1675
- Review panel
- CH
- Medical specialty
- Clinical Chemistry
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Market data
- Cleared 510(k) submissions
- 7
- Registered establishments
- 6
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown