FDA product code REM: Spectroscopy Instrument
REM is the FDA product code for spectroscopy instrument. It is a Not classified device, reviewed by the Unknown panel. FDA has posted 5 recalls for REM devices, 2 initiated in the last five years.
Definition
Product, laser, instrument, spectroscopy; An instrument incorporating a laser for spectroscopic testing or examination
Classification
| Field | Value |
|---|---|
| Device name | Spectroscopy Instrument |
| Device class | Not classified |
| Medical specialty | Unknown |
| GMP exempt | Yes |
Recalls for REM devices
5 product recalls in 5 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-08-04.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code REM?
REM is the FDA product code for spectroscopy instrument. It is a Not classified device, reviewed by the Unknown panel.
What device class is REM?
Not classified.
Have REM devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2025-08-04.
Next steps
- Run an FDA pathway report with predicate devices for product code REM
- Run a recall and safety report across every REM manufacturer
- Watch product code REM 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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