Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes
The Thymol Blue Monophosphate, Alkaline Phosphatase or Isoenzymes test system (product code CJH) is an in-vitro diagnostic device used in clinical chemistry to measure alkaline phosphatase activity or its isoenzymes in serum using thymol blue monophosphate as a substrate, supporting the assessment of liver 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 862.1050 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- CJH
- Device Class
- FDA class 2
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K792551 | ALKALINE PHOSPHATASE REAGENT | Jan 29, 1980 | Substantially Equivalent | Electrophoresis Corp. of America |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.