Product code OTR ยท Class N
Research Use Only/Immunology Devices
0510(k)s in 12 months (0 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in OTR
| Company | 510(k)s | Recalls |
|---|---|---|
| Diagnostic Hybrids, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2015 | Diagnostic Hybrids, Inc. MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum. Terminated |
OTR | None listed |
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