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FDA 510(k)

COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY

K-Number: K936253 · 1995-09-08

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

Device Summary

COXSACKIEVIRUS B4 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 K936253. The device is classified under product code GNM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY?

COXSACKIEVIRUS B4 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 K936253.

When did COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY receive FDA 510(k) clearance?

COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY received FDA 510(k) clearance on 1995-09-08, under 510(k) number K936253.

Who is the listed applicant for COXSACKIEVIRUS B4 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 COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY?

The FDA product code for COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY is GNM.

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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: GNM)

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.

K936145COXSACKIEVIRUS B1 MONOCLONAL ANTIBODYChemicon Intl., Inc.K936252COXSACKIEVIRUS B@ MONOCLONAL ANTIBODYLight DiagnosticsK936073ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUSChemicon Intl., Inc.K936251COXSACKIEVIRUS B3 MONOCLONAL ANTIBODYLight DiagnosticsK936254COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODYLight DiagnosticsK940471COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIESChemicon Intl., 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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