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FDA 510(k)

FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD

K-Number: K792249 · 1980-01-23

ApplicantIntl. Diagnostic Technology
Decision Date1980-01-23
Product CodeGOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD 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 1980-01-23 under 510(k) number K792249. The device is classified under product code GOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD?

FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD is a medical device that received FDA 510(k) clearance on 1980-01-23. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K792249.

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

FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD received FDA 510(k) clearance on 1980-01-23, under 510(k) number K792249.

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

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-RUBELLA ANTIBOD?

The FDA product code for FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD is GOL.

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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: GOL)

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.

K841174RUBELLA ANTIBODY FLUOROIMMUNOASSAYIntl. Diagnostic TechnologyK834032RUBAQUICK DIAGNOSTIC KITAbbott LaboratoriesK810309RUBELLA ANTIBODIES TEST REAGENTSCalbiochem-Behring Corp.K802508RUBELISA IGM TEST KITM.A. BioproductsK802102RUBELLA ELISA REAGENTS RUBELLA IGG ANTICalbiochem-Behring Corp.K802339EIA RUBELLA-GBeckman Instruments, 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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