FDA 510(k)

FIAX IGG TEST KIT

K-Number: K831609 · 1983-06-17

Decision Date1983-06-17

Product CodeDGK

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

FIAX IGG 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 1983-06-17 under 510(k) number K831609. The device is classified under product code DGK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAX IGG TEST KIT?

FIAX IGG TEST KIT is a medical device that received FDA 510(k) clearance on 1983-06-17. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K831609.

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

FIAX IGG TEST KIT received FDA 510(k) clearance on 1983-06-17, under 510(k) number K831609.

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

The FDA product code for FIAX IGG TEST KIT is DGK.

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 KIT K843570FIAX HAPTOGLOBIN TEST KIT K843621FIAX 420 DILUTOR K843356FIAX 100 FLUOROMETER K842749FIAX TOTAL IGE TEST KIT K842071FIAX TRANSFERRIN TEST KIT

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Related Devices (Code: DGK)

K831908RABBIT ANTISERUM TO HUMAN IGGDako 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.