Cleared Traditional

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)

K170005 · Dako Denmark A/S · Pathology
Dec 2017
Decision
352d
Days
Class 2
Risk

About This 510(k) Submission

K170005 is an FDA 510(k) clearance for the FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis), a Immunohistochemistry Assay, Antibody, Progesterone Receptor (Class II — Special Controls, product code MXZ), 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 K170005 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 MXZ — Immunohistochemistry Assay, Antibody, Progesterone Receptor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.1860

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