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FDA 510(k)

LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295

K-Number: K990141 · 1999-10-19

ApplicantLight Diagnostics
Decision Date1999-10-19
Product CodeGQW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 is the device name listed in this FDA 510(k) record. The listed applicant is Light Diagnostics. It received FDA 510(k) clearance on 1999-10-19 under 510(k) number K990141. The device is classified under product code GQW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295?

LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 is a medical device that received FDA 510(k) clearance on 1999-10-19. The listed applicant is Light Diagnostics. The 510(k) number is K990141.

When did LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 receive FDA 510(k) clearance?

LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 received FDA 510(k) clearance on 1999-10-19, under 510(k) number K990141.

Who is the listed applicant for LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295?

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 HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295?

The FDA product code for LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 is GQW.

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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 ASSAYK972975LIGHT DIAGNOSTICS RABIES DFA REAGENTK974302LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU BK951821CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAYK951799VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAYK940017POLIOVIRUS 3 MONOCLONAL ANTIBODY

View all 19 devices →

Related Devices (Code: GQW)

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.

K070206DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000Diagnostic Hybrids, Inc.K964872VZV ANTIGEN CONTROL SLIDESViral Antigens, Inc.K942743VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENTViro Research, Inc.K912239VZVSCAN(TM) LATEX AGGUTINATION TESTBd Becton Dickinson Vacutainer Systems PreanalyticK903882VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGGViral Antigens, Inc.K894622VARICELLA ZOSTER VIRUSBion Ent., Ltd.

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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