FDA product code JII: Atomic Absorption, Lithium
JII is the FDA product code for atomic absorption, lithium. It is a Class II device, regulated under 21 CFR 862.3560 and reviewed by the Clinical Toxicology panel. FDA has cleared 3 510(k) submissions under JII, from 3 different applicants. The average 510(k) review took 131 days (median 144).
Classification
| Field | Value |
|---|---|
| Device name | Atomic Absorption, Lithium |
| Device class | Class II |
| Regulation | 21 CFR 862.3560 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JII clearance
Top JII applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diazyme Laboratories | 1 | 2008-12-05 |
| General Atomics | 1 | 2003-12-23 |
| In Wha Pharmaceutical Co., Ltd. | 1 | 1991-11-22 |
Most recent JII clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K082001 | Diazyme Laboratories | DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B | 2008-12-05 | 144 |
| K033360 | General Atomics | DIAZYME LITHIUM ENZYMATIC ASSAY KIT | 2003-12-23 | 63 |
| K912244 | In Wha Pharmaceutical Co., Ltd. | UROTEST GPH | 1991-11-22 | 185 |
Recalls for JII devices
openFDA lists no recalls for product code JII.
Frequently asked questions
What is FDA product code JII?
JII is the FDA product code for atomic absorption, lithium. It is a Class II device, regulated under 21 CFR 862.3560 and reviewed by the Clinical Toxicology panel.
What device class is JII?
Class II, regulation 21 CFR 862.3560. Typical premarket route: 510(k).
How long does a 510(k) take for product code JII?
Across 3 cleared submissions the average was 131 days from receipt to decision (median 144).
Which companies have the most JII clearances?
Diazyme Laboratories (1); General Atomics (1); In Wha Pharmaceutical Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JII
- Run a recall and safety report across every JII manufacturer
- Watch product code JII 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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