MyCare Psychiatry Clozapine Assay Kit
FDA 510(k) clearance DEN190028 · decided 2020-04-16
Clearance details
- K-number
- DEN190028
- Device name
- MyCare Psychiatry Clozapine Assay Kit
- Applicant
- Saladax Biomedical, Inc.
- Decision
- Unknown
- Date received
- 2019-05-24
- Decision date
- 2020-04-16
- Days to decision
- 328 days
- Clearance type
- Direct
- Product code
- QKT
- Device class
- 2
- Regulation number
- 862.3245
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.