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FDA 510(k)

IDT ANA STIQ ASSAY

K-Number: K832383 · 1983-08-31

ApplicantIntl. Diagnostic Technology
Decision Date1983-08-31
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IDT ANA STIQ ASSAY 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 1983-08-31 under 510(k) number K832383. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDT ANA STIQ ASSAY?

IDT ANA STIQ ASSAY is a medical device that received FDA 510(k) clearance on 1983-08-31. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K832383.

When did IDT ANA STIQ ASSAY receive FDA 510(k) clearance?

IDT ANA STIQ ASSAY received FDA 510(k) clearance on 1983-08-31, under 510(k) number K832383.

Who is the listed applicant for IDT ANA STIQ ASSAY?

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 IDT ANA STIQ ASSAY?

The FDA product code for IDT ANA STIQ ASSAY is DHN.

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Other records listing Intl. Diagnostic Technology as applicant

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Related Devices (Code: DHN)

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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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