← FDA Medical Device Classifications
Enzymatic Radiochemical Assay, Amikacin
LDN · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3035
Classification
- FDA Product Code
LDN- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 862.3035
- Review panel
- TX
- Medical specialty
- Clinical Toxicology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Market data
- Cleared 510(k) submissions
- 3
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown