FDA 510(k)

HDL REAGENT

K-Number: K800996 · 1980-05-14

Decision Date1980-05-14

Product CodeLBR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

HDL 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 1980-05-14 under 510(k) number K800996. The device is classified under product code LBR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDL REAGENT?

HDL REAGENT is a medical device that received FDA 510(k) clearance on 1980-05-14. The listed applicant is Gilford Diagnostics. The 510(k) number is K800996.

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

HDL REAGENT received FDA 510(k) clearance on 1980-05-14, under 510(k) number K800996.

Who is the listed applicant for HDL 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 HDL REAGENT?

The FDA product code for HDL REAGENT is LBR.

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Other records listing Gilford Diagnostics as applicant

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Related Devices (Code: LBR)

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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.