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FDA 510(k)

FIAX TOTAL IGE TEST KIT

K-Number: K842749 · 1984-08-28

ApplicantIntl. Diagnostic Technology
Decision Date1984-08-28
Product CodeDGP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIAX TOTAL IGE TEST KIT 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 1984-08-28 under 510(k) number K842749. The device is classified under product code DGP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAX TOTAL IGE TEST KIT?

FIAX TOTAL IGE TEST KIT is a medical device that received FDA 510(k) clearance on 1984-08-28. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K842749.

When did FIAX TOTAL IGE TEST KIT receive FDA 510(k) clearance?

FIAX TOTAL IGE TEST KIT received FDA 510(k) clearance on 1984-08-28, under 510(k) number K842749.

Who is the listed applicant for FIAX TOTAL IGE TEST KIT?

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 TOTAL IGE TEST KIT?

The FDA product code for FIAX TOTAL IGE TEST KIT is DGP.

Related Clinical Trials

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.

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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 FLUOROMETERK842071FIAX TRANSFERRIN TEST KITK841174RUBELLA ANTIBODY FLUOROIMMUNOASSAY

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Related Devices (Code: DGP)

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.

K931224VIDAS TOTAL IGE (IGE) ASSAYBiomerieux Vitek, Inc.K863327IMMPULSE IGE ASSAY REAGENTSSclavo, Inc.K842969ALLERGENETICS ALLER-SPECIFIC IGE SERUMAllergenetics

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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