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FDA 510(k)

POLIOVIRUS 1 MONOCLONAL ANTIBODY

K-Number: K940018 · 1995-09-08

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

Device Summary

POLIOVIRUS 1 MONOCLONAL 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 K940018. 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 POLIOVIRUS 1 MONOCLONAL ANTIBODY?

POLIOVIRUS 1 MONOCLONAL 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 K940018.

When did POLIOVIRUS 1 MONOCLONAL ANTIBODY receive FDA 510(k) clearance?

POLIOVIRUS 1 MONOCLONAL ANTIBODY received FDA 510(k) clearance on 1995-09-08, under 510(k) number K940018.

Who is the listed applicant for POLIOVIRUS 1 MONOCLONAL 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 POLIOVIRUS 1 MONOCLONAL ANTIBODY?

The FDA product code for POLIOVIRUS 1 MONOCLONAL 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 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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