QKT
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Clozapine Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3245
- Medical specialty
- Clinical Chemistry
- FDA definition
- A clozapine test system is intended for the in vitro quantitative measurement of clozapine in human specimens.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| MyCare Psychiatry Clozapine Assay Kit (DEN190028) | Saladax Biomedical, Inc. | 2020-04-16 |
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