FDA 510(k)

VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)

K-Number: K990618 · 1999-07-23

Decision Date1999-07-23

Product CodeMXZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc.. It received FDA 510(k) clearance on 1999-07-23 under 510(k) number K990618. The device is classified under product code MXZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)?

VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) is a medical device that received FDA 510(k) clearance on 1999-07-23. The listed applicant is Ventana Medical Systems, Inc.. The 510(k) number is K990618.

When did VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) receive FDA 510(k) clearance?

VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) received FDA 510(k) clearance on 1999-07-23, under 510(k) number K990618.

Who is the listed applicant for VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)?

The FDA 510(k) record lists Ventana Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)?

The FDA product code for VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) is MXZ.

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Other records listing Ventana Medical Systems, Inc. as applicant

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Related Devices (Code: MXZ)

K193393BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).Leica Biosystems Newcastle, Ltd.K183102BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal AntibodyLeica Biosystems Newcastle, Limited K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)Dako Denmark A/S K171753BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16Leica Biosystems Newcastle, Limited K160922FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)Dako North America, Inc.K130861MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)Dako North America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.