510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K890887Substantially Equivalent

Abuscreen Fp for Cannabinoids

Roche Diagnostic Systems, Inc., Montclair NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890887 is the FDA 510(k) clearance record for ABUSCREEN FP FOR CANNABINOIDS, a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code LDJ (Enzyme Immunoassay, Cannabinoids). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K890887.

Clearance record

Decision date
Received
(23 days to decision)
Product code
LDJ Enzyme Immunoassay, Cannabinoids
Regulation
21 CFR 862.3870
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Roche Diagnostic Systems, Inc. One Sunset Ave., Montclair NJ
Third party review
No

Clearances, product code LDJ

Trailing 12 months

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

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