510(k) K955116
- Device
- Benzodiazepines By Remedi Hs
- Applicant
- BIO-RAD
- 510(k) number
- K955116
- Product code
- LAA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-01-30
- Date received
- 1995-11-09
- Regulation
- 862.3170
- Classification name
- High Pressure Liquid Chromatography, Benzodiazepine
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVEN R BINDER
- Address
- 4000 Alfred Nobel Dr. Hercules CA US 94547 94547