510(k) K941596
- Device
- Remedi Hs Drug Profiling System
- Applicant
- BIO-RAD
- 510(k) number
- K941596
- Product code
- DNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-27
- Date received
- 1994-04-01
- Regulation
- 862.3100
- Classification name
- Liquid Chromatography, Amphetamine
- 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
- JOHN NELSON
- Address
- 4000 Alfred Nobel Dr. Hercules CA US 94547 94547
FDA Registration Numbers#
- 3005360469
- 2246703
- 2517506