← FDA Medical Device Classifications
Calibrator, Primary
JIS · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1150
Classification
- FDA Product Code
JIS- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 862.1150
- Review panel
- CH
- Medical specialty
- Clinical Chemistry
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 130
- Registered establishments
- 72
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown