Microzyme THC Enzyme Immunoassay Test Kit
FDA 510(k) K904635 · Immunotech Corp.
510(k) numberK904635
Submission
- Device name
- Microzyme THC Enzyme Immunoassay Test Kit
- Applicant
- Immunotech Corp.
Boston, MA, US - Received
- October 11, 1990
- Decision date
- November 1, 1990
- 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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Questions and answers
When was Microzyme THC Enzyme Immunoassay Test Kit cleared by the FDA?
Microzyme THC Enzyme Immunoassay Test Kit (K904635) received a 510(k) decision of Substantially Equivalent on November 1, 1990, 21 days after the submission was received.
What is the product code of K904635?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.