LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls

FDA 510(k) K141320 · Lin-Zhi International, Inc.

Substantially Equivalent

510(k) numberK141320

Submission

Device name
LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls
Applicant
Lin-Zhi International, Inc.
Sunnyvale, CA, US
Received
May 20, 2014
Decision date
May 28, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LDJ – Enzyme Immunoassay, Cannabinoids
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3870
Specialty
Clinical Toxicology

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Questions and answers

When was LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls cleared by the FDA?

LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls (K141320) received a 510(k) decision of Substantially Equivalent on May 28, 2015, 373 days after the submission was received.

What is the product code of K141320?

The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.