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

Name: FDA 510(k) clearance K170028
Creator: U.S. Food and Drug Administration
Published: 2017-12-21

Substantially Equivalent

Dako Denmark A/S

FDA 510(k) clearance K170028 for FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis), Substantially Equivalent on 2017-12-21. Applicant: Dako Denmark A/S. Device class: 2.

Clearance details

Applicant: Dako Denmark A/S
Product code: Code MYA
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2017-01-03
Decision date: 2017-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golstrup, DK

Download summary PDF View on FDA.gov ↗

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