510(k) K823829
- Device
- Ferritin Immunoradiometric Assay Kit
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K823829
- Product code
- DFB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-03-11
- Date received
- 1982-12-20
- Regulation
- 866.5130
- Classification name
- Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Related Records
Applicant Contact
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
Source Documents
510(k) summary PDF not indicated by FDA