Emit(R) II Cannabinoid 100 NG Assay
FDA 510(k) K904568 · Syva Co.
510(k) numberK904568
Submission
- Device name
- Emit(R) II Cannabinoid 100 NG Assay
- Applicant
- Syva Co.
Palo Alto, CA, US - Received
- October 9, 1990
- Decision date
- December 26, 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 Emit(R) II Cannabinoid 100 NG Assay cleared by the FDA?
Emit(R) II Cannabinoid 100 NG Assay (K904568) received a 510(k) decision of Substantially Equivalent on December 26, 1990, 78 days after the submission was received.
What is the product code of K904568?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.