510(k) K862649 ยท DAK Complement C1q, Antigen, Antiserum, Control
CYTOTECH CIC ENZYME IMMUNOASSAY
| Applicant | Cytotech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 4, 1986 |
| Received | Jul 11, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862649
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2017 | Diagnostic Hybrids, Inc. MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma.
The assay uses highly pure, functional human C1q coated in the soli Terminated |
DAK | None listed |
| Nov 3, 2015 | Diagnostic Hybrids, Inc. MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma.
The MicroVue CIC-C1q EIA is for detection of circulating im Terminated |
DAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.