510(k) K811637
- Device
- Rubella Latex Card Test
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K811637
- Product code
- DOK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-08-13
- Date received
- 1981-06-10
- Regulation
- 862.3640
- Classification name
- Free Radical Assay, Morphine
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Related Records
Applicant Contact
- Address
- 1875 Eye St. NW Suite 625 Washington DC US 20006 20006
Source Documents
510(k) summary PDF not indicated by FDA