510(k) K790059
- Device
- PROACTIVATOR C3, C4 AND C3
- Applicant
- ICL SCIENTIFIC
- 510(k) number
- K790059
- Product code
- KTP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-03-15
- Date received
- 1979-01-09
- Regulation
- 866.5260
- Classification name
- Complement C3b Activator Immunoassay Reagents
- 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
Legacy Summary#
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FDA Review#
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