Synchron Systems Cannabinoid 20 NG Reagent
FDA 510(k) K955677 · Beckman Instruments, Inc.
510(k) numberK955677
Submission
- Device name
- Synchron Systems Cannabinoid 20 NG Reagent
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- December 15, 1995
- Decision date
- April 3, 1996
- 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 Synchron Systems Cannabinoid 20 NG Reagent cleared by the FDA?
Synchron Systems Cannabinoid 20 NG Reagent (K955677) received a 510(k) decision of Substantially Equivalent on April 3, 1996, 110 days after the submission was received.
What is the product code of K955677?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.