Company ยท DK
Dako Denmark A/S
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2017. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 21, 2017 | K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) Dako Denmark A/S, DK | MYA |
| Dec 21, 2017 | K170005 | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) Dako Denmark A/S, DK | MXZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2020 | Dako Denmark A/S Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800. Terminated |
KPA | None listed |
| Jul 6, 2016 | Dako Denmark A/S EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004.
Intended for use in immunohistochemistry together with Autostainer Link Instruments. Terminated |
LDT | None listed |
| Dec 19, 2012 | Dako Denmark A/S CoverStainer Slide Rack
The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides, during transfer through the staining process. The rack c Terminated |
KPA | None listed |