510(k) K790899
- Device
- Bactec
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K790899
- Product code
- KLP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-05-23
- Date received
- 1979-05-09
- Regulation
- 862.3035
- Classification name
- Amikacin Serum Assay
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 1875 Eye St. NW Suite 625 Washington DC US 20006 20006
FDA Registration Numbers#
- 3006198300
- 3003795116
- 9610126
- 9610529
Source Documents#
510(k) summary PDF not indicated by FDA