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FDA 510(k)

ENTEROVIRUS 70 MONCLONAL ANTIBODY

K-Number: K940363 · 1995-09-08

ApplicantLight Diagnostics
Decision Date1995-09-08
Product CodeGOE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENTEROVIRUS 70 MONCLONAL ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Light Diagnostics. It received FDA 510(k) clearance on 1995-09-08 under 510(k) number K940363. 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 70 MONCLONAL ANTIBODY?

ENTEROVIRUS 70 MONCLONAL ANTIBODY is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Light Diagnostics. The 510(k) number is K940363.

When did ENTEROVIRUS 70 MONCLONAL ANTIBODY receive FDA 510(k) clearance?

ENTEROVIRUS 70 MONCLONAL ANTIBODY received FDA 510(k) clearance on 1995-09-08, under 510(k) number K940363.

Who is the listed applicant for ENTEROVIRUS 70 MONCLONAL ANTIBODY?

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

What is the FDA product code for ENTEROVIRUS 70 MONCLONAL ANTIBODY?

The FDA product code for ENTEROVIRUS 70 MONCLONAL ANTIBODY is GOE.

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Other records listing Light Diagnostics 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.

K991880LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAYK990141LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295K972975LIGHT DIAGNOSTICS RABIES DFA REAGENTK974302LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU BK951821CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAYK951799VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY

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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.K940473ENTEROVIRUS 71 MONOCLONAL ANTIBODYChemicon Intl., Inc.K940017POLIOVIRUS 3 MONOCLONAL ANTIBODYLight DiagnosticsK940034POLIOVIRUS 2 MONOCLONAL ANTIBODYLight DiagnosticsK940026POLIOVIRUS BLEND MONOCLONAL ANTIBODIESLight DiagnosticsK940018POLIOVIRUS 1 MONOCLONAL 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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