510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN190028Unknown

MyCare Psychiatry Clozapine Assay Kit

Saladax Biomedical, Inc., Bethlehem PA / Direct, Unknown
FDA source (opens on fda.gov)

DEN190028 is the FDA 510(k) clearance record for MyCare Psychiatry Clozapine Assay Kit, a class II device, cleared for Saladax Biomedical, Inc. on under FDA product code QKT (Clozapine Test System). FDA's definition for product code QKT reads: "A clozapine test system is intended for the in vitro quantitative measurement of clozapine in human specimens". FDA records list one 510(k) clearance for Saladax Biomedical, Inc. As of , FDA records show no recalls naming DEN190028.

Clearance record

Decision date
Received
(328 days to decision)
Product code
QKT Clozapine Test System
Regulation
21 CFR 862.3245
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Saladax Biomedical, Inc. 116 Research Dr., Bethlehem PA
Third party review
No

Clearances, product code QKT

Trailing 12 months

FDA records hold no clearances under product code QKT in the trailing twelve months.

FDA records show no clearances under product code QKT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QKT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260