510(k) K770866
- Device
- RABBIT COMPLEMENT
- Applicant
- Cedarlake Labs , Ltd.
- 510(k) number
- K770866
- Product code
- DHL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-06-03
- Date received
- 1977-05-11
- Regulation
- 866.4100
- Classification name
- Protein, Complement, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3004061467
- 3019906
- 3016548670
Source Documents#
510(k) summary PDF not indicated by FDA