510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151395Substantially Equivalent

Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets

Immunalysis Corporation, Pomona CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151395 is the FDA 510(k) clearance record for Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets, a class II device, cleared for Immunalysis Corporation on under FDA product code DJR (Enzyme Immunoassay, Methadone). FDA records list 50 510(k) clearances for Immunalysis Corporation, from to . As of , FDA records show one recall naming K151395.

Clearance record

Decision date
Received
(59 days to decision)
Product code
DJR Enzyme Immunoassay, Methadone
Regulation
21 CFR 862.3620
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Immunalysis Corporation 829 Towne Center Dr., Pomona CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DJR

Trailing 12 months

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

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