Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
The Alpha-Naphthyl Phosphate, Alkaline Phosphatase or Isoenzymes test system (product code CJO) is an in-vitro diagnostic device used in clinical chemistry to measure alkaline phosphatase activity or its isoenzymes in serum using alpha-naphthyl phosphate as substrate with colorimetric detection of released naphthol. 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
- CJO
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K122323 | DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI | Aug 28, 2012 | Substantially Equivalent | Siemens Healthcare Diagnostics |
| K121907 | DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR | Jul 23, 2012 | Substantially Equivalent | Siemens Healthcare Diagnostics |
| K982328 | BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Jan 29, 1999 | Substantially Equivalent | Bayer Corp. |
| K770155 | ALKALINE PHOSPHATASE ISOYZME REAGENT SET | Jan 31, 1977 | Substantially Equivalent | Gelman Instrument Co. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.