Panels › Immunology › Product code DAK · Class 2
Complement C1q, Antigen, Antiserum, Control
Regulation 866.5240
0510(k)s in 12 months (28 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in DAK
| Company | 510(k)s | Recalls |
|---|---|---|
| Ortho Diagnostic Systems, Inc. | 3 | 0 |
| The Binding Site, Ltd. | 2 | 0 |
| Biostar Medical Products, Inc. | 2 | 0 |
| Cytotech, Inc. | 2 | 0 |
| Diagnostic Hybrids, Inc. | 0 | 2 |
| Gamma Medical Products, Inc. | 2 | 0 |
| Hyland Therapeutic Div., Travenol Laboratories | 2 | 0 |
| Icl Scientific | 2 | 0 |
| American Laboratory Products Co., Ltd. | 1 | 0 |
| Collaborative Research, Inc. | 1 | 0 |
| 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 | K862649 |
| 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 | K862649 |
| Jun 30, 2010 | Inova Diagnostics Incorporated Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021 Terminated |
DAK | K031563 |
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