← FDA Medical Device Classifications
Hemoglobin A1c Test System
PDJ · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1373
Classification
- FDA Product Code
PDJ- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 862.1373
- Review panel
- CH
- Medical specialty
- Clinical Chemistry
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Market data
- Cleared 510(k) submissions
- 26
- Registered establishments
- 34
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown