510(k) K170028— FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)

Substantially Equivalent

Dako Denmark A/S

Clearance details

Applicant: Dako Denmark A/S
Product code: Code MYA
Advisory panel: Hematology
Date received: 2017-01-03
Decision date: 2017-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golstrup, DK

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