510(k) K771583
- Device
- FLUORESCENT ANTI. ANTI-HUMAN C3
- Applicant
- Burroughs Wellcome Co.
- 510(k) number
- K771583
- Product code
- DAC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-09-02
- Date received
- 1977-08-18
- Regulation
- 866.5260
- Classification name
- Complement C3b Activator, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3019906
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DAC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K891904 | EZ COMPLEMENT C1 | Diamedix Corp. | 1989-04-14 |