Microplate Cannabinoids Assay
FDA 510(k) K924815 · Solarcare Technologies Corp,Inc.
510(k) numberK924815
Submission
- Device name
- Microplate Cannabinoids Assay
- Applicant
- Solarcare Technologies Corp,Inc.
Bethlehem, PA, US - Received
- September 25, 1992
- Decision date
- January 26, 1993
- 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 Microplate Cannabinoids Assay cleared by the FDA?
Microplate Cannabinoids Assay (K924815) received a 510(k) decision of Substantially Equivalent on January 26, 1993, 123 days after the submission was received.
What is the product code of K924815?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.