510(k) K760045
- Device
- Kit, Radioassay, Serum Iron
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K760045
- Product code
- JJA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-07-20
- Date received
- 1976-06-15
- Regulation
- 862.1410
- Classification name
- Radio-Labeled Iron Method, Iron (Non-Heme)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- 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