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FDA 510(k)

CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY

K-Number: K951821 · 1996-06-07

ApplicantLight Diagnostics
Decision Date1996-06-07
Product CodeLIN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Light Diagnostics. It received FDA 510(k) clearance on 1996-06-07 under 510(k) number K951821. The device is classified under product code LIN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY?

CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY is a medical device that received FDA 510(k) clearance on 1996-06-07. The listed applicant is Light Diagnostics. The 510(k) number is K951821.

When did CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY receive FDA 510(k) clearance?

CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY received FDA 510(k) clearance on 1996-06-07, under 510(k) number K951821.

Who is the listed applicant for CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY?

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 CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY?

The FDA product code for CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY is LIN.

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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 BK951799VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAYK940017POLIOVIRUS 3 MONOCLONAL ANTIBODY

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Related Devices (Code: LIN)

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.

K081164D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KITDiagnostic Hybrids, Inc.K983762NUCLISENS CMV PP67Organon Teknika Corp.K991650CMV BRITE TURBO KITBiotest Diagnostics Corp.K951550CMV BRITE ANTIGENEMIA TEST KITBiotest Diagnostics Corp.K934798PATHODX CYTOMEGALOVIRUSDiagnostic Products Corp.K921616CMV-VUE(TM) CMV ANTIGEN DETECTION KITIncstar 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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