FDA product code SIC: Tempo Pilot Ckm: Cardio-Kidney-Metabolic
SIC is the FDA product code for tempo pilot ckm: cardio-kidney-metabolic. It is a Not classified device, reviewed by the Clinical Chemistry panel. Devices under SIC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
TEMPO Pilot: cardio-kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease)
Classification
| Field | Value |
|---|---|
| Device name | Tempo Pilot Ckm: Cardio-Kidney-Metabolic |
| Device class | Not classified |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for SIC devices
openFDA lists no recalls for product code SIC.
Frequently asked questions
What is FDA product code SIC?
SIC is the FDA product code for tempo pilot ckm: cardio-kidney-metabolic. It is a Not classified device, reviewed by the Clinical Chemistry panel.
What device class is SIC?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code SIC
- Run a recall and safety report across every SIC manufacturer
- Watch product code SIC 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times