510(k) K891904
- Device
- EZ COMPLEMENT C1
- Applicant
- DIAMEDIX CORP.
- 510(k) number
- K891904
- Product code
- DAC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-04-14
- Date received
- 1989-03-27
- 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
- No
Applicant Contact#
- Contact
- DAVID J KIEFER,PH.D
- Address
- 2140 N. Miami Ave. Miami FL US 33127 33127
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 |
|---|---|---|---|
| K771583 | FLUORESCENT ANTI. ANTI-HUMAN C3 | Burroughs Wellcome Co. | 1977-09-02 |
Legacy Summary#
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FDA Review#
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