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FDA 510(k)

FIAX IGA TEST KIT

K-Number: K831607 · 1983-06-22

ApplicantIntl. Diagnostic Technology
Decision Date1983-06-22
Product CodeCZN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIAX IGA 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 1983-06-22 under 510(k) number K831607. The device is classified under product code CZN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAX IGA TEST KIT?

FIAX IGA TEST KIT is a medical device that received FDA 510(k) clearance on 1983-06-22. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K831607.

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

FIAX IGA TEST KIT received FDA 510(k) clearance on 1983-06-22, under 510(k) number K831607.

Who is the listed applicant for FIAX IGA 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 IGA TEST KIT?

The FDA product code for FIAX IGA TEST KIT is CZN.

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: CZN)

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.

K891683TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISERHelena LaboratoriesK855011QUANTIMETRIC PLUS C3 REAGENT KITKallestad Laboratories, Inc.K841815OPTIMATE IGA TESTMiles Laboratories, Inc.K832262FITC GOAT ANTI-HUMAN IMMUNOGLOBULINSGelco Diagnostics, Inc.K832257GOAT ANTI-HUMAN IGA A CHAIN SPECIFICGelco Diagnostics, Inc.K831909RABBIT ANTISERUM TO HUMAN IGADako 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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