510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011054Substantially Equivalent

Rads

Chason Healthcare, LLC, Rock Hill SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011054 is the FDA 510(k) clearance record for RADS, a class II device, cleared for Chason Healthcare, LLC on under FDA product code DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites). FDA records list one 510(k) clearance for Chason Healthcare, LLC. As of , FDA records show no recalls naming K011054.

Clearance record

Decision date
Received
(115 days to decision)
Product code
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Regulation
21 CFR 862.3250
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Chason Healthcare, LLC 715 Buckeye Ter., Rock Hill SC
510(k) summary
Statement
Third party review
No

Clearances, product code DIO

Trailing 12 months

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

FDA records show no clearances under product code DIO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DIO, 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