FDA product code SAL: Device, Automated Cell Locating, Bone Marrow
SAL is the FDA product code for device, automated cell locating, bone marrow. It is a Class II device, regulated under 21 CFR 864.5261 and reviewed by the Hematology panel. Devices under SAL reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
An automated cell-locating device for bone marrow aspirate is an in vitro diagnostic device intended for prescription use that automatically locates and presents images of hematopoietic cells on a bone marrow aspirate smear obtained from patients being evaluated for hematologic diseases. The device assists operators to identify and classify each cell according to type.
Classification
| Field | Value |
|---|---|
| Device name | Device, Automated Cell Locating, Bone Marrow |
| Device class | Class II |
| Regulation | 21 CFR 864.5261 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for SAL devices
openFDA lists no recalls for product code SAL.
Frequently asked questions
What is FDA product code SAL?
SAL is the FDA product code for device, automated cell locating, bone marrow. It is a Class II device, regulated under 21 CFR 864.5261 and reviewed by the Hematology panel.
What device class is SAL?
Class II, regulation 21 CFR 864.5261. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SAL
- Run a recall and safety report across every SAL manufacturer
- Watch product code SAL 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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