FDA product code JLK: Sodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity
JLK is the FDA product code for sodium hydroxide and phenol red (titrimetric), gastric acidity. It is a Class I device, regulated under 21 CFR 862.1320 and reviewed by the Clinical Chemistry panel. Devices under JLK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Sodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity |
| Device class | Class I |
| Regulation | 21 CFR 862.1320 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JLK devices
openFDA lists no recalls for product code JLK.
Frequently asked questions
What is FDA product code JLK?
JLK is the FDA product code for sodium hydroxide and phenol red (titrimetric), gastric acidity. It is a Class I device, regulated under 21 CFR 862.1320 and reviewed by the Clinical Chemistry panel.
What device class is JLK?
Class I, regulation 21 CFR 862.1320. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JLK
- Run a recall and safety report across every JLK manufacturer
- Watch product code JLK 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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