510(k) K881345
- Device
- Imx Ferritin
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K881345
- Product code
- DGD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-05-11
- Date received
- 1988-03-30
- Regulation
- 866.5510
- Classification name
- Igg, Ferritin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MATT KLAMRZYNSKI
- Address
- One Abbott Park Rd. Abbott Park IL US 60064 60064
Source Documents#
510(k) summary PDF not indicated by FDA