FDA 510(k)

ASI REAGENT

K-Number: K800065 · 1980-02-05

Decision Date1980-02-05

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ASI REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1980-02-05 under 510(k) number K800065. The device is classified under product code CIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASI REAGENT?

ASI REAGENT is a medical device that received FDA 510(k) clearance on 1980-02-05. The listed applicant is Gilford Diagnostics. The 510(k) number is K800065.

When did ASI REAGENT receive FDA 510(k) clearance?

ASI REAGENT received FDA 510(k) clearance on 1980-02-05, under 510(k) number K800065.

Who is the listed applicant for ASI REAGENT?

The FDA 510(k) record lists Gilford Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASI REAGENT?

The FDA product code for ASI REAGENT is CIT.

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Related Devices (Code: CIT)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.