510(k) K760881
- Device
- Febrile Antigen Control Sera
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K760881
- Product code
- GSZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-11-09
- Date received
- 1976-10-21
- Regulation
- 866.3410
- Classification name
- Antigens, Febrile (Weil-Felix), All Groups
- 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
FDA Registration Numbers#
- 3003750284
- 1649661
- 2250030
Source Documents#
510(k) summary PDF not indicated by FDA