510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894464Substantially Equivalent

Abuscreen Positive Reference Controls

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

K894464 is the FDA 510(k) clearance record for ABUSCREEN POSITIVE REFERENCE CONTROLS, a class I device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code LAS (Drug Specific Control Materials). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K894464.

Clearance record

Decision date
Received
(39 days to decision)
Product code
LAS Drug Specific Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Roche Diagnostic Systems, Inc. One Sunset Ave., Montclair NJ
Third party review
No

Clearances, product code LAS

Trailing 12 months

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

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