FDA 510(k)

FIAX IGG TEST

K-Number: K832821 · 1983-10-14

Decision Date1983-10-14

Product CodeDFI

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

FIAX IGG TEST 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 1983-10-14 under 510(k) number K832821. The device is classified under product code DFI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAX IGG TEST?

FIAX IGG TEST is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K832821.

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

FIAX IGG TEST received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832821.

Who is the listed applicant for FIAX IGG TEST?

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?

The FDA product code for FIAX IGG TEST is DFI.

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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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.