510(k) K780012
- Device
- Antithrombin Iii Ria
- Applicant
- RIA DIAGNOSTICS
- 510(k) number
- K780012
- Product code
- DDQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-01-20
- Date received
- 1978-01-03
- Regulation
- 864.7060
- Classification name
- Antigen, Antiserum, Control, Antithrombin Iii
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2050010
- 2050012
Source Documents#
510(k) summary PDF not indicated by FDA