510(k) K812076
- Device
- Anti-gm & Anti-km Typing Serums
- Applicant
- BIOTEST-SERUM-INSTITUT
- 510(k) number
- K812076
- Product code
- DGH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-08-12
- Date received
- 1981-07-22
- Regulation
- 866.5510
- Classification name
- Igd, Peroxidase, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA