FDA product code CJO: Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
CJO is the FDA product code for alpha-naphthyl phosphate, alkaline phosphatase or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1050 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under CJO, from 3 different applicants. The average 510(k) review took 67 days (median 26). FDA has posted 1 recall for CJO devices.
Classification
| Field | Value |
|---|---|
| Device name | Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes |
| Device class | Class II |
| Regulation | 21 CFR 862.1050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CJO clearance
Top CJO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Healthcare Diagnostics | 2 | 2012-08-28 |
| Bayer Corp. | 1 | 1999-01-29 |
| Gelman Instrument Co. | 1 | 1977-01-31 |
Most recent CJO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122323 | Siemens Healthcare Diagnostics | DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI | 2012-08-28 | 27 |
| K121907 | Siemens Healthcare Diagnostics | DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR | 2012-07-23 | 24 |
| K982328 | Bayer Corp. | BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | 1999-01-29 | 211 |
| K770155 | Gelman Instrument Co. | ALKALINE PHOSPHATASE ISOYZME REAGENT SET | 1977-01-31 | 7 |
Recalls for CJO devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-08-25.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code CJO?
CJO is the FDA product code for alpha-naphthyl phosphate, alkaline phosphatase or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1050 and reviewed by the Clinical Chemistry panel.
What device class is CJO?
Class II, regulation 21 CFR 862.1050. Typical premarket route: 510(k).
How long does a 510(k) take for product code CJO?
Across 4 cleared submissions the average was 67 days from receipt to decision (median 26).
Which companies have the most CJO clearances?
Siemens Healthcare Diagnostics (2); Bayer Corp. (1); Gelman Instrument Co. (1).
Have CJO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-08-25.
Next steps
- Run an FDA pathway report with predicate devices for product code CJO
- Run a recall and safety report across every CJO manufacturer
- Watch product code CJO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times