CHW
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Titrimetric With Edta And Indicator, Calcium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1145
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2023: 22 · 2024: 23 · 2025: 22 · 2026: 17
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 |
|---|---|---|
| CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV (K192730) | Biosystems S.A. | 2020-09-09 |
| CALCIUM GEN. 2 (K113521) | Roche Diagnostics | 2012-05-08 |
| LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA (K781454) | Union Carbide Corp. | 1978-09-20 |
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Every clearance here is in the API, with alerts when new ones post.