510(k) K823520
- Device
- Fibrosystem
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K823520
- Product code
- GKQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-12-28
- Date received
- 1982-11-29
- Regulation
- 864.7900
- Classification name
- Test, Thromboplastin Generation
- Medical specialty
- Hematology
- Review panel
- Hematology
- 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#
- 3010194621
Source Documents#
510(k) summary PDF not indicated by FDA