← FDA Medical Device Classifications
U.V. Method, Cpk Isoenzymes
JHW · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1215
Classification
- FDA Product Code
JHW- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 862.1215
- 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
- 27
- Registered establishments
- 6
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown