QKT — Clozapine Test System Class II
FDA product code QKT covers "Clozapine Test System", a Class II medical device regulated under 21 CFR 862.3245. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QKT
- Device Class
- Class II
- Regulation Number
- 862.3245
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
A clozapine test system is intended for the in vitro quantitative measurement of clozapine in human specimens.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN190028 | saladax biomedical | MyCare Psychiatry Clozapine Assay Kit | April 16, 2020 |