Cleared Traditional

VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)

K990618 · Ventana Medical Systems, Inc. · Pathology
Jul 1999
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K990618 is an FDA 510(k) clearance for the VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6), a Immunohistochemistry Assay, Antibody, Progesterone Receptor (Class II — Special Controls, product code MXZ), submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on July 23, 1999, 148 days after receiving the submission on February 25, 1999. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K990618 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 1999
Decision Date July 23, 1999
Days to Decision 148 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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