FDA product code LSM: Dna-Reagents, Salmonella Spp.
LSM is the FDA product code for dna-reagents, salmonella spp.. It is a Class II device, regulated under 21 CFR 866.3550 and reviewed by the Microbiology panel. Devices under LSM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for LSM devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dna-Reagents, Salmonella Spp. |
| Device class | Class II |
| Regulation | 21 CFR 866.3550 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for LSM devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-09.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code LSM?
LSM is the FDA product code for dna-reagents, salmonella spp.. It is a Class II device, regulated under 21 CFR 866.3550 and reviewed by the Microbiology panel.
What device class is LSM?
Class II, regulation 21 CFR 866.3550. Typical premarket route: 510(k) exempt.
Have LSM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code LSM
- Run a recall and safety report across every LSM manufacturer
- Watch product code LSM 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 Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times