FDA product code SDK: Transdermal Test For Assessment Of Glomerular Filtration Rate
SDK is the FDA product code for transdermal test for assessment of glomerular filtration rate. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under SDK reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
A test used to assess a patients glomerular filtration rate (GFR) by injecting a fluorescent tracer molecule into the blood stream and measuring the amount of fluorescence through the skin with a transdermal sensor.
Classification
| Field | Value |
|---|---|
| Device name | Transdermal Test For Assessment Of Glomerular Filtration Rate |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for SDK devices
openFDA lists no recalls for product code SDK.
Frequently asked questions
What is FDA product code SDK?
SDK is the FDA product code for transdermal test for assessment of glomerular filtration rate. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is SDK?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SDK
- Run a recall and safety report across every SDK manufacturer
- Watch product code SDK 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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