Benzodiazepines by Remedi HS
FDA 510(k) K955116 · Bio-Rad
510(k) numberK955116
Submission
- Device name
- Benzodiazepines by Remedi HS
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- November 9, 1995
- Decision date
- January 30, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LAA – High Pressure Liquid Chromatography, Benzodiazepine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3170
- Specialty
- Clinical Toxicology
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Questions and answers
When was Benzodiazepines by Remedi HS cleared by the FDA?
Benzodiazepines by Remedi HS (K955116) received a 510(k) decision of Substantially Equivalent on January 30, 1996, 82 days after the submission was received.
What is the product code of K955116?
The FDA product code is LAA – High Pressure Liquid Chromatography, Benzodiazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3170.