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FDA 510(k)

LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124

K-Number: K093815 · 2010-03-12

ApplicantMillipore Corporation
Decision Date2010-03-12
Product CodeOMG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 is the device name listed in this FDA 510(k) record. The listed applicant is Millipore Corporation. It received FDA 510(k) clearance on 2010-03-12 under 510(k) number K093815. The device is classified under product code OMG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124?

LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 is a medical device that received FDA 510(k) clearance on 2010-03-12. The listed applicant is Millipore Corporation. The 510(k) number is K093815.

When did LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 receive FDA 510(k) clearance?

LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 received FDA 510(k) clearance on 2010-03-12, under 510(k) number K093815.

Who is the listed applicant for LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124?

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

What is the FDA product code for LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124?

The FDA product code for LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 is OMG.

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Other records listing Millipore Corporation 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.

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Related Devices (Code: OMG)

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.

K093233D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KITDiagnostic Hybrids, Inc.K091171D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KITDiagnostic Hybrids, Inc.K090073D3 DFA METAPNEUMOVIRUS IDENTIFICATION KITDiagnostic Hybrids, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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