Remedi HS Drug Profiling System
FDA 510(k) K941596 · Bio-Rad
510(k) numberK941596
Submission
- Device name
- Remedi HS Drug Profiling System
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- April 1, 1994
- Decision date
- March 27, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DNI – Liquid Chromatography, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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Questions and answers
When was Remedi HS Drug Profiling System cleared by the FDA?
Remedi HS Drug Profiling System (K941596) received a 510(k) decision of Substantially Equivalent on March 27, 1995, 360 days after the submission was received.
What is the product code of K941596?
The FDA product code is DNI – Liquid Chromatography, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.