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FDA 510(k)

LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B

K-Number: K974302 · 1998-04-08

ApplicantLight Diagnostics
Decision Date1998-04-08
Product CodeGNW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B is the device name listed in this FDA 510(k) record. The listed applicant is Light Diagnostics. It received FDA 510(k) clearance on 1998-04-08 under 510(k) number K974302. The device is classified under product code GNW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B?

LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B is a medical device that received FDA 510(k) clearance on 1998-04-08. The listed applicant is Light Diagnostics. The 510(k) number is K974302.

When did LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B receive FDA 510(k) clearance?

LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B received FDA 510(k) clearance on 1998-04-08, under 510(k) number K974302.

Who is the listed applicant for LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B?

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 LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B?

The FDA product code for LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B is GNW.

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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 REAGENTK951821CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAYK951799VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAYK940017POLIOVIRUS 3 MONOCLONAL ANTIBODY

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Related Devices (Code: GNW)

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.

K092882D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KITDiagnostic Hybrids, Inc.K092300MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KITDiagnostic Hybrids, Inc.K081746D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KITDiagnostic Hybrids, Inc.K061101D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KITDiagnostic Hybrids, Inc.K022713DFA RESPIRATORY VIRUS SCREENING & ID KITDiagnostic Hybrids, Inc.K003204BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KITIntracel Corp.

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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