Abuscreen Online Cannabinoids Calibrators

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K910085 ↗

FDA Product Code

DKB

Device Class

Class II

Regulation

21 CFR Part 862.3200

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Roche Diagnostic Systems, Inc. →

• What is the primary purpose of the Abuscreen Online Cannabinoids Calibrators?

  These calibrators are intended for use in clinical toxicology settings. Their specific function is to establish a reliable reference point for the measurement of cannabinoids within a laboratory environment.

• How is this device classified for regulatory purposes?

  The Abuscreen Online Cannabinoids Calibrators are categorized as a Class II medical device. They are regulated under 21 CFR 862.3200 and received FDA 510(k) clearance under the number K910085.

• Who is the manufacturer of this device?

  This device is manufactured by Roche Diagnostic Systems, Inc., located in Montclair, New Jersey.