CFG
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Oil Emulsion/Thymolphthalein (Titrimetric), Lipase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1465
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SERUM LIPASE REAGENT SET (TURBIDIMETRIC) (K860554) | Sterling Diagnostics, Inc. | 1986-03-14 |
| LIPASE DETERMINATION (K800550) | The Dow Chemical Co. | 1980-04-02 |
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