Cleared Traditional

DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING

K020023 · Dako Corp. · Pathology
Feb 2002
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K020023 is an FDA 510(k) clearance for the DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING, a Immunohistochemistry Assay, Antibody, Progesterone Receptor (Class II — Special Controls, product code MXZ), submitted by Dako Corp. (Carpinteria, US). The FDA issued a Cleared decision on February 28, 2002, 56 days after receiving the submission on January 3, 2002. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K020023 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2002
Decision Date February 28, 2002
Days to Decision 56 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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