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FDA 510(k)

ANTINUCLEAR ANTIBODY IMMUNOLOGICAL

K-Number: K833984 · 1984-01-04

ApplicantIntl. Diagnostic Technology
Decision Date1984-01-04
Product CodeKTL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTINUCLEAR ANTIBODY IMMUNOLOGICAL 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 1984-01-04 under 510(k) number K833984. The device is classified under product code KTL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTINUCLEAR ANTIBODY IMMUNOLOGICAL?

ANTINUCLEAR ANTIBODY IMMUNOLOGICAL is a medical device that received FDA 510(k) clearance on 1984-01-04. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K833984.

When did ANTINUCLEAR ANTIBODY IMMUNOLOGICAL receive FDA 510(k) clearance?

ANTINUCLEAR ANTIBODY IMMUNOLOGICAL received FDA 510(k) clearance on 1984-01-04, under 510(k) number K833984.

Who is the listed applicant for ANTINUCLEAR ANTIBODY IMMUNOLOGICAL?

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 ANTINUCLEAR ANTIBODY IMMUNOLOGICAL?

The FDA product code for ANTINUCLEAR ANTIBODY IMMUNOLOGICAL is KTL.

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Other records listing Intl. Diagnostic Technology as applicant

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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: KTL)

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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.

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