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FDA 510(k)

ABBOTT IMX GLYCATED HEMOGLOBIN II

K-Number: K992085 · 2000-05-25

ApplicantAbbott Laboratories
Decision Date2000-05-25
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ABBOTT IMX GLYCATED HEMOGLOBIN II is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2000-05-25 under 510(k) number K992085. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT IMX GLYCATED HEMOGLOBIN II?

ABBOTT IMX GLYCATED HEMOGLOBIN II is a medical device that received FDA 510(k) clearance on 2000-05-25. The listed applicant is Abbott Laboratories. The 510(k) number is K992085.

When did ABBOTT IMX GLYCATED HEMOGLOBIN II receive FDA 510(k) clearance?

ABBOTT IMX GLYCATED HEMOGLOBIN II received FDA 510(k) clearance on 2000-05-25, under 510(k) number K992085.

Who is the listed applicant for ABBOTT IMX GLYCATED HEMOGLOBIN II?

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

What is the FDA product code for ABBOTT IMX GLYCATED HEMOGLOBIN II?

The FDA product code for ABBOTT IMX GLYCATED HEMOGLOBIN II is LCP.

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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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