510(k) DEN190028
- Device
- MyCare Psychiatry Clozapine Assay Kit
- Applicant
- Saladax Biomedical, Inc.
- 510(k) number
- DEN190028
- Product code
- QKT
- Decision
- Unknown (DENG)
- Decision date
- 2020-04-16
- Date received
- 2019-05-24
- Regulation
- 862.3245
- Classification name
- Clozapine Test System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Sue Werner
- Address
- 116 Research Dr. Bethlehem PA US 18015 18015
FDA Registration Numbers#
- 3005567065
Source Documents#
510(k) summary PDF not indicated by FDA