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FDA 510(k)

FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS

K-Number: K791948 · 1979-11-16

ApplicantIntl. Diagnostic Technology
Decision Date1979-11-16
Product CodeGQH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic Technology. It received FDA 510(k) clearance on 1979-11-16 under 510(k) number K791948. 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 FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS?

FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS is a medical device that received FDA 510(k) clearance on 1979-11-16. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K791948.

When did FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS receive FDA 510(k) clearance?

FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS received FDA 510(k) clearance on 1979-11-16, under 510(k) number K791948.

Who is the listed applicant for FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS?

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

What is the FDA product code for FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS?

The FDA product code for FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS is GQH.

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Other records listing Intl. Diagnostic Technology 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.

K850591FIAX TOXO-M ANTIBODIES TEST KITK843570FIAX HAPTOGLOBIN TEST KITK843621FIAX 420 DILUTORK843356FIAX 100 FLUOROMETERK842749FIAX TOTAL IGE TEST KITK842071FIAX TRANSFERRIN TEST KIT

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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.K935809CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAYLight DiagnosticsK882835INDIRECT FLUORESCENT ASSAY FOR (HCMV)Stellar Bio Systems, Inc.K882024FITC MURINE MONOCLONAL ANTI-CMV IGGWhittaker Bioproducts, Inc.K881932ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENTOrtho Diagnostic Systems, Inc.

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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