510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913867Substantially Equivalent

Urine Cocaine Metabolite Direct Ria Kit (I-125)

Immunalysis Corporation, Glendale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913867 is the FDA 510(k) clearance record for URINE COCAINE METABOLITE DIRECT RIA KIT (I-125), a class II device, cleared for Immunalysis Corporation on under FDA product code KLN (Radioimmunoassay, Cocaine Metabolite). FDA records list 50 510(k) clearances for Immunalysis Corporation, from to . As of , FDA records show no recalls naming K913867.

Clearance record

Decision date
Received
(23 days to decision)
Product code
KLN Radioimmunoassay, Cocaine Metabolite
Regulation
21 CFR 862.3250
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Immunalysis Corporation 1707 Gardena Ave., Glendale CA
510(k) summary
Statement
Third party review
No

Clearances, product code KLN

Trailing 12 months

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

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