510(k) DEN190028
DEN190028 is an FDA 510(k) premarket notification submitted by Saladax Biomedical, Inc. for the device "MyCare Psychiatry Clozapine Assay Kit". The FDA issued a decision of De Novo Granted on April 16, 2020. The device falls under product code QKT (Clozapine Test System), a Class II device regulated under 21 CFR 862.3245.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 16, 2020
- Date Received
- May 24, 2019
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clozapine Test System
- Device Class
- Class II
- Regulation Number
- 862.3245
- Review Panel
- TX
- Submission Type
A clozapine test system is intended for the in vitro quantitative measurement of clozapine in human specimens.