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FDA 510(k)

ENTEROVIRUS 71 MONOCLONAL ANTIBODY

K-Number: K940473 · 1995-09-12

ApplicantChemicon Intl., Inc.
Decision Date1995-09-12
Product CodeGOE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENTEROVIRUS 71 MONOCLONAL ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Chemicon Intl., Inc.. It received FDA 510(k) clearance on 1995-09-12 under 510(k) number K940473. The device is classified under product code GOE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTEROVIRUS 71 MONOCLONAL ANTIBODY?

ENTEROVIRUS 71 MONOCLONAL ANTIBODY is a medical device that received FDA 510(k) clearance on 1995-09-12. The listed applicant is Chemicon Intl., Inc.. The 510(k) number is K940473.

When did ENTEROVIRUS 71 MONOCLONAL ANTIBODY receive FDA 510(k) clearance?

ENTEROVIRUS 71 MONOCLONAL ANTIBODY received FDA 510(k) clearance on 1995-09-12, under 510(k) number K940473.

Who is the listed applicant for ENTEROVIRUS 71 MONOCLONAL ANTIBODY?

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

What is the FDA product code for ENTEROVIRUS 71 MONOCLONAL ANTIBODY?

The FDA product code for ENTEROVIRUS 71 MONOCLONAL ANTIBODY is GOE.

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Other records listing Chemicon Intl., Inc. 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.

K992252LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965K940027ENTEROVIRUS BLEND MONOCLONAL ANTIBODIESK936073ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUSK936089COXSACKIE A24 VIRUS MONOCLONAL ANTIBODYK940472COXSACKIEVIRUS B5 MONOCLONAL ANTIBODYK940471COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES

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Related Devices (Code: GOE)

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.

K940027ENTEROVIRUS BLEND MONOCLONAL ANTIBODIESChemicon Intl., Inc.K940017POLIOVIRUS 3 MONOCLONAL ANTIBODYLight DiagnosticsK940034POLIOVIRUS 2 MONOCLONAL ANTIBODYLight DiagnosticsK940026POLIOVIRUS BLEND MONOCLONAL ANTIBODIESLight DiagnosticsK940018POLIOVIRUS 1 MONOCLONAL ANTIBODYLight DiagnosticsK940363ENTEROVIRUS 70 MONCLONAL ANTIBODYLight Diagnostics

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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