Thermo Scientific Cedia Cannabinoids Oft Assay
FDA 510(k) K101744 · Microgenics Corp.
510(k) numberK101744
Submission
- Device name
- Thermo Scientific Cedia Cannabinoids Oft Assay
- Applicant
- Microgenics Corp.
Fremont Blvd., CA, US - Received
- June 22, 2010
- Decision date
- April 8, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Thermo Scientific Cedia Cannabinoids Oft Assay cleared by the FDA?
Thermo Scientific Cedia Cannabinoids Oft Assay (K101744) received a 510(k) decision of Substantially Equivalent on April 8, 2011, 290 days after the submission was received.
What is the product code of K101744?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.