Panels › Immunology › Product code KTO · Class 1
Reagent, Immunoassay, Igg
Regulation 866.5530
0510(k)s in 12 months (2 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in KTO
| Company | 510(k)s | Recalls |
|---|---|---|
| Kallestad Laboratories, Inc. | 1 | 0 |
| Reagents Applications, Inc. | 1 | 0 |
| Ventana Medical Systems Inc | 0 | 1 |
| Vitrolife Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2015 | Vitrolife Inc SpermMar Test
0.7ml Beads Particles
Label on bottle:
SpermMar Test IgA
0.7ml Beads/Particles-50 Tests
IND REF SPMA_S
LOT Expiration
DO NOT FREEZE/NE PAS CONGELER
FertiPro N.V.
Label on box:
SpermM Terminated |
KTO | None listed |
| Jun 17, 2003 | Ventana Medical Systems Inc iVIEW DAB Detecion Kit.
Catalog Number 760-091 Terminated |
KTO | None listed |
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