Cleared Traditional

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

K170028 · Dako Denmark A/S · Pathology
Dec 2017
Decision
352d
Days
Class 2
Risk

About This 510(k) Submission

K170028 is an FDA 510(k) clearance for the FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis), a Immunohistochemistry Antibody Assay, Estrogen Receptor (Class II — Special Controls, product code MYA), submitted by Dako Denmark A/S (Golstrup, DK). The FDA issued a Cleared decision on December 21, 2017, 352 days after receiving the submission on January 3, 2017. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K170028 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2017
Decision Date December 21, 2017
Days to Decision 352 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code MYA — Immunohistochemistry Antibody Assay, Estrogen Receptor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.1860

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