Acid Phosphatase, Thymol Blue Monophosphate
The Acid Phosphatase, Thymol Blue Monophosphate test system (product code CJR) is an in-vitro diagnostic device used in clinical chemistry to measure acid phosphatase activity in serum using thymol blue monophosphate as a substrate under acidic conditions, supporting the assessment of prostate and bone disease. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1020 in the Clinical Chemistry medical specialty.
Research product code CJR in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- CJR
- Device Class
- FDA class 2
- Regulation Number
- 862.1020
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.