Cx(Tm) Cannabinoid 50NG(THC5) Reagent/Synchron CX Sys
FDA 510(k) K944086 · Beckman Instruments, Inc.
510(k) numberK944086
Submission
- Device name
- Cx(Tm) Cannabinoid 50NG(THC5) Reagent/Synchron CX Sys
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- July 5, 1994
- Decision date
- December 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Cx(Tm) Cannabinoid 50NG(THC5) Reagent/Synchron CX Sys cleared by the FDA?
Cx(Tm) Cannabinoid 50NG(THC5) Reagent/Synchron CX Sys (K944086) received a 510(k) decision of Substantially Equivalent on December 29, 1994, 177 days after the submission was received.
What is the product code of K944086?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.