FDA product code CJJ: Diazo, Alt/Sgpt
CJJ is the FDA product code for diazo, alt/sgpt. It is a Class I device, regulated under 21 CFR 862.1030 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under CJJ, from 2 different applicants. The average 510(k) review took 110 days (median 110).
Classification
| Field | Value |
|---|---|
| Device name | Diazo, Alt/Sgpt |
| Device class | Class I |
| Regulation | 21 CFR 862.1030 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CJJ clearance
Top CJJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Prisma Systems | 1 | 1994-12-09 |
| Biotrack, Inc. | 1 | 1989-10-06 |
Most recent CJJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K943003 | Prisma Systems | CALCIUM QVET | 1994-12-09 | 169 |
| K895128 | Biotrack, Inc. | BIOTRACK ALT TEST CARTRIDGE | 1989-10-06 | 50 |
Recalls for CJJ devices
openFDA lists no recalls for product code CJJ.
Frequently asked questions
What is FDA product code CJJ?
CJJ is the FDA product code for diazo, alt/sgpt. It is a Class I device, regulated under 21 CFR 862.1030 and reviewed by the Clinical Chemistry panel.
What device class is CJJ?
Class I, regulation 21 CFR 862.1030. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CJJ?
Across 2 cleared submissions the average was 110 days from receipt to decision (median 110).
Which companies have the most CJJ clearances?
Prisma Systems (1); Biotrack, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CJJ
- Run a recall and safety report across every CJJ manufacturer
- Watch product code CJJ 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.
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