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FDA 510(k)

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)

K-Number: K170028 · 2017-12-21

ApplicantDako Denmark A/S
Decision Date2017-12-21
Product CodeMYA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) is a medical device manufactured by Dako Denmark A/S. It received FDA 510(k) clearance on 2017-12-21 under approval number K170028. The device is classified under product code MYA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)?

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) is a medical device that received FDA 510(k) clearance on 2017-12-21. It is manufactured by Dako Denmark A/S. The 510(k) number is K170028.

When was FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) approved by the FDA?

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) received FDA 510(k) clearance on 2017-12-21, under approval number K170028.

What company makes FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)?

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) is manufactured by Dako Denmark A/S.

What is the FDA product code for FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)?

The FDA product code for FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) is MYA.

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Other Devices by Dako Denmark A/S

K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) PMA P100024Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer

Related Devices (Code: MYA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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