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MyCare Psychiatry Clozapine Assay Kit

DEN190028 Class II Direct
Decision Date
2020-04-16
Sponsor / Applicant
Saladax Biomedical, Inc.

Technical Specification

510(k) Submission ID DEN190028
Product Code QKT
Medical Specialty / Panel Clinical Chemistry
Regulation Citation 21 CFR 862.3245
Decision Date 2020-04-16
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

MyCare Psychiatry Clozapine Assay Kit received FDA 510(k) clearance under submission number DEN190028, sponsored by Saladax Biomedical, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2020-04-16.

Classification & Regulation

This clearance is catalogued under FDA product code QKT and 21 CFR 862.3245, within the Clinical Chemistry review panel as a Class II device.