510(k) K830363
- Device
- Bactec 170 Tryptic Soy Broth W/resins
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K830363
- Product code
- LJF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-03-24
- Date received
- 1983-02-04
- Regulation
- 866.2560
- Classification name
- Device, Antimicrobial Drug Removal
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 1875 Eye St. NW Suite 625 Washington DC US 20006 20006
Source Documents#
510(k) summary PDF not indicated by FDA