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FDA 510(k)

ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS

K-Number: K936073 · 1995-09-08

ApplicantChemicon Intl., Inc.
Decision Date1995-09-08
Product CodeGNM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS 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 1995-09-08 under 510(k) number K936073. 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 ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS?

ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Chemicon Intl., Inc.. The 510(k) number is K936073.

When did ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS receive FDA 510(k) clearance?

ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS received FDA 510(k) clearance on 1995-09-08, under 510(k) number K936073.

Who is the listed applicant for ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS?

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 MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS?

The FDA product code for ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS is GNM.

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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 31965K940473ENTEROVIRUS 71 MONOCLONAL ANTIBODYK940027ENTEROVIRUS BLEND MONOCLONAL ANTIBODIESK940472COXSACKIEVIRUS B5 MONOCLONAL ANTIBODYK940471COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIESK936145COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY

View all 8 devices →

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.

K936253COXSACKIEVIRUS B4 MONOCLONAL ANTIBODYLight DiagnosticsK936145COXSACKIEVIRUS B1 MONOCLONAL ANTIBODYChemicon Intl., Inc.K936252COXSACKIEVIRUS B@ MONOCLONAL ANTIBODYLight DiagnosticsK936251COXSACKIEVIRUS 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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