Cannabinoid Assay and the Randox Cannabinoid Calibrator/ Control Set
FDA 510(k) K092269 · Randox Laboratories, Ltd.
510(k) numberK092269
Submission
- Device name
- Cannabinoid Assay and the Randox Cannabinoid Calibrator/ Control Set
- Applicant
- Randox Laboratories, Ltd.
Crumlin, GB - Received
- July 28, 2009
- Decision date
- April 8, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Cannabinoid Assay and the Randox Cannabinoid Calibrator/ Control Set cleared by the FDA?
Cannabinoid Assay and the Randox Cannabinoid Calibrator/ Control Set (K092269) received a 510(k) decision of Substantially Equivalent on April 8, 2011, 619 days after the submission was received.
What is the product code of K092269?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.