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FDA 510(k)

ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS

K-Number: K834140 · 1984-01-20

ApplicantIntl. Diagnostic Technology
Decision Date1984-01-20
Product CodeKTL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS 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 1984-01-20 under 510(k) number K834140. 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 SYS?

ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS is a medical device that received FDA 510(k) clearance on 1984-01-20. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K834140.

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

ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS received FDA 510(k) clearance on 1984-01-20, under 510(k) number K834140.

Who is the listed applicant for ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS?

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 SYS?

The FDA product code for ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS is KTL.

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Other records listing Intl. Diagnostic Technology as applicant

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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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