LXG
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Medical specialty
- Clinical Chemistry
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2017: 14 · 2018: 25 · 2019: 27 · 2020: 15 · 2022: 13 · 2025: 1,253
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM (K021927) | Biomet, Inc. | 2002-07-12 |
| MINI S.F.T. (URINE PRESERVATIVE) (K943466) | Cambridge Diagnostic Products, Inc. | 1995-05-24 |
| MAGNET PAD (K896802) | Westmark, Sterile Packing Systems, Inc. (Sps) | 1989-12-27 |
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Every clearance here is in the API, with alerts when new ones post.