510(k) K850768
- Device
- Toxoscan Card Test Kit
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K850768
- Product code
- LLA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-05-20
- Date received
- 1985-02-25
- Regulation
- 866.3780
- Classification name
- Direct Agglutination Test, Toxoplasma Gondii
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUSSELL ARNSBERGER
- Address
- 1875 Eye St. NW Suite 625 Washington DC US 20006 20006
FDA Registration Numbers#
- 2029372
- 3005360469
Source Documents#
510(k) summary PDF not indicated by FDA