MyCare Psychiatry Clozapine Assay Kit— 510(k) DEN190028

Name: FDA 510(k) clearance DEN190028
Creator: U.S. Food and Drug Administration
Published: 2020-04-16

Unknown

Saladax Biomedical, Inc.

FDA 510(k) clearance DEN190028 for MyCare Psychiatry Clozapine Assay Kit, Unknown on 2020-04-16. Applicant: Saladax Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Saladax Biomedical, Inc.
Product code: Code QKT
Device class: Class 2
Regulation: 21 CFR 862.3245
Advisory panel: Clinical Chemistry
Date received: 2019-05-24
Decision date: 2020-04-16
Decision: Unknown
Clearance type: Direct
Location: Bethlehem, PA, US

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