← FDA Medical Device Classifications
Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
NQN · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.1860
Classification
- FDA Product Code
NQN- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 864.1860
- Review panel
- PA
- Medical specialty
- Hematology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.
Market data
- Cleared 510(k) submissions
- 15
- Registered establishments
- 2
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown