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FDA 510(k)

CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY

K-Number: K935809 · 1994-05-05

ApplicantLight Diagnostics
Decision Date1994-05-05
Product CodeGQH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CYTOMEGALOVIRUS INDIRECT 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 1994-05-05 under 510(k) number K935809. The device is classified under product code GQH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY?

CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY is a medical device that received FDA 510(k) clearance on 1994-05-05. The listed applicant is Light Diagnostics. The 510(k) number is K935809.

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

CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY received FDA 510(k) clearance on 1994-05-05, under 510(k) number K935809.

Who is the listed applicant for CYTOMEGALOVIRUS INDIRECT 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 INDIRECT IMMUNOFLUORESCENCE ASSAY?

The FDA product code for CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY is GQH.

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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 BK951821CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAYK951799VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY

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Related Devices (Code: GQH)

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.

K982311BARTELS CINAKIT CMV ANTIGENEMIAIntracel Corp.K964875CMV ANTIGEN CONTROL SLIDESViral Antigens, Inc.K882835INDIRECT FLUORESCENT ASSAY FOR (HCMV)Stellar Bio Systems, Inc.K882024FITC MURINE MONOCLONAL ANTI-CMV IGGWhittaker Bioproducts, Inc.K881932ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENTOrtho Diagnostic Systems, Inc.K880679BION CMV-G TEST SYSTEMBion 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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