Genie Cup Integrated Screening Device
FDA 510(k) K980836 · Applied Technology Ventures, LLC
510(k) numberK980836
Submission
- Device name
- Genie Cup Integrated Screening Device
- Applicant
- Applied Technology Ventures, LLC
Rockville, MD, US - Received
- March 4, 1998
- Decision date
- June 29, 1998
- 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 Genie Cup Integrated Screening Device cleared by the FDA?
Genie Cup Integrated Screening Device (K980836) received a 510(k) decision of Substantially Equivalent on June 29, 1998, 117 days after the submission was received.
What is the product code of K980836?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.