510(k) K893753
- Device
- Directigen 1-2-3 Disseminated Candidiasis Test
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K893753
- Product code
- LHK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-16
- Date received
- 1989-05-19
- Regulation
- 866.3165
- Classification name
- Antigen, Id, Candida Albicans
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- J ARNSBERGER
- Address
- 1 Becton Dr. Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 3024463179
- 3005360469
- 3016837106
Source Documents#
510(k) summary PDF not indicated by FDA