FDA product code JIK: Dry Ash Method, Protein-Bound Iodine
JIK is the FDA product code for dry ash method, protein-bound iodine. It is a Class I device, regulated under 21 CFR 862.1640 and reviewed by the Clinical Chemistry panel. Devices under JIK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Dry Ash Method, Protein-Bound Iodine |
| Device class | Class I |
| Regulation | 21 CFR 862.1640 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JIK devices
openFDA lists no recalls for product code JIK.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J9264 — Injection, paclitaxel protein-bound particles, 1 mg
Frequently asked questions
What is FDA product code JIK?
JIK is the FDA product code for dry ash method, protein-bound iodine. It is a Class I device, regulated under 21 CFR 862.1640 and reviewed by the Clinical Chemistry panel.
What device class is JIK?
Class I, regulation 21 CFR 862.1640. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JIK
- Run a recall and safety report across every JIK manufacturer
- Watch product code JIK 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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