DIE
5 FDA 510(k) clearances · Product code
56 daysmedian time to decision
272 days90th percentile
5clearances measured
FDA profile
- Official device name
- Heavy Metals Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Medical specialty
- Clinical Toxicology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 (K020610) | Bio-Rad | 2002-04-22 |
| LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 (K990928) | Bio-Rad | 1999-04-16 |
| LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II (K891691) | Bio-Rad | 1989-12-19 |
| SHAPE-ACTIO METAL TOXICOLOGY CONTROL (K890721) | Actio, Inc. | 1989-04-10 |
| SHAPE-ACTIO METAL TOXICOLOGY CONTROL (K863915) | Shape Products Co. | 1986-11-24 |
Track DIE automatically
Every clearance here is in the API, with alerts when new ones post.