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FDA 510(k)

BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)

K-Number: K013148 · 2002-02-28

ApplicantBiogenex Laboratories
Decision Date2002-02-28
Product CodeMYA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) is the device name listed in this FDA 510(k) record. The listed applicant is Biogenex Laboratories. It received FDA 510(k) clearance on 2002-02-28 under 510(k) number K013148. The device is classified under product code MYA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)?

BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) is a medical device that received FDA 510(k) clearance on 2002-02-28. The listed applicant is Biogenex Laboratories. The 510(k) number is K013148.

When did BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) receive FDA 510(k) clearance?

BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) received FDA 510(k) clearance on 2002-02-28, under 510(k) number K013148.

Who is the listed applicant for BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)?

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-ESTROGEN RECEPTOR(CLONE ER88)?

The FDA product code for BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) is MYA.

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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.

K012960BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTORK925189PREGNAGEN 1-STEP PREGNANCY TESTK902208MODIFIED OVUGENK884880PREGNAGEN(TM)K882002PREGNAGEN(TM)K873534OVUGEN SURETEST

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Related Devices (Code: MYA)

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.

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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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