← FDA Medical Device Classifications
Uric Acid Test System For At Home Prescription Use
PTC · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1775
Classification
- FDA Product Code
PTC- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 862.1775
- Review panel
- CH
- Medical specialty
- Clinical Chemistry
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.
Market data
- Cleared 510(k) submissions
- 3
- Registered establishments
- 5
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown