Cleared Traditional

NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2)

K060462 · Lab Vision Corp. · Pathology
Apr 2006
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K060462 is an FDA 510(k) clearance for the NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2), a Immunohistochemistry Assay, Antibody, Progesterone Receptor (Class II — Special Controls, product code MXZ), submitted by Lab Vision Corp. (Fremont, US). The FDA issued a Cleared decision on April 24, 2006, 61 days after receiving the submission on February 22, 2006. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K060462 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2006
Decision Date April 24, 2006
Days to Decision 61 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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