510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K895906Substantially Equivalent

Abuscreen Ontrak for Phencyclidine (Pcp)

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

K895906 is the FDA 510(k) clearance record for ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP), cleared for Roche Diagnostic Systems, Inc. on under FDA product code LCM (Enzyme Immunoassay, Phencyclidine). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K895906.

Clearance record

Decision date
Received
(112 days to decision)
Product code
LCM Enzyme Immunoassay, Phencyclidine
Device class
Unclassified
Review panel
Unknown
Applicant
Roche Diagnostic Systems, Inc. One Sunset Ave., Montclair NJ
Third party review
No

Clearances, product code LCM

Trailing 12 months

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

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