Cannabinoid Enzyme Immunoassay Kit
FDA 510(k) K872882 · General Diagnostics
510(k) numberK872882
Submission
- Device name
- Cannabinoid Enzyme Immunoassay Kit
- Applicant
- General Diagnostics
Great Neck, NY, US - Received
- July 22, 1987
- Decision date
- November 3, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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More from Healgen Scientific,, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K882663 | Barbiturate Enzyme Immunoassay KitDIS · Traditional | 09/19/1988SE |
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| K863877 | Benzodiazepine Enzyme Immunoassay KitJXM · Traditional | 03/12/1987SE |
| K842307 | General Diag. Cefonicid 30MCG AntimicJTN · Traditional | 07/20/1984SE |
| K841465 | General Diagnostics Platelet AntibodyLLG · Traditional | 07/02/1984SE |
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| K831179 | Cefazolin 30MCG. Antimicrobial SuscepJTN · Traditional | 05/09/1983SE |
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Questions and answers
When was Cannabinoid Enzyme Immunoassay Kit cleared by the FDA?
Cannabinoid Enzyme Immunoassay Kit (K872882) received a 510(k) decision of Substantially Equivalent on November 3, 1987, 104 days after the submission was received.
What is the product code of K872882?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.