GJZ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cyanomethemoglobin Reagent And Standard Solution
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7500
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| HEMOGLOBIN (K883683) | Tech-Co, Inc. | 1988-10-06 |
| CELL-DYN RAPID-LYSE AND HEMOGLOBLIN (K881242) | Abbott Diagnostics | 1988-04-21 |
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