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FDA 510(k)

BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR

K-Number: K012960 · 2002-03-08

ApplicantBiogenex Laboratories
Decision Date2002-03-08
Product CodeMXZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Biogenex Laboratories. It received FDA 510(k) clearance on 2002-03-08 under 510(k) number K012960. 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 BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR?

BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR is a medical device that received FDA 510(k) clearance on 2002-03-08. The listed applicant is Biogenex Laboratories. The 510(k) number is K012960.

When did BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR receive FDA 510(k) clearance?

BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR received FDA 510(k) clearance on 2002-03-08, under 510(k) number K012960.

Who is the listed applicant for BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR?

The FDA 510(k) record lists Biogenex Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR?

The FDA product code for BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR is MXZ.

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Other records listing Biogenex Laboratories as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K013148BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)K925189PREGNAGEN 1-STEP PREGNANCY TESTK902208MODIFIED OVUGENK884880PREGNAGEN(TM)K882002PREGNAGEN(TM)K873534OVUGEN SURETEST

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Related Devices (Code: MXZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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, LimitedK170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)Dako Denmark A/SK171753BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16Leica Biosystems Newcastle, LimitedK160922FLEX 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.

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