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FDA 510(k)

IMX(R) GLYCATED HEMOGLOBIN

K-Number: K921831 · 1992-09-29

ApplicantAbbott Laboratories
Decision Date1992-09-29
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IMX(R) GLYCATED HEMOGLOBIN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1992-09-29 under 510(k) number K921831. 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 IMX(R) GLYCATED HEMOGLOBIN?

IMX(R) GLYCATED HEMOGLOBIN is a medical device that received FDA 510(k) clearance on 1992-09-29. The listed applicant is Abbott Laboratories. The 510(k) number is K921831.

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

IMX(R) GLYCATED HEMOGLOBIN received FDA 510(k) clearance on 1992-09-29, under 510(k) number K921831.

Who is the listed applicant for IMX(R) GLYCATED HEMOGLOBIN?

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 IMX(R) GLYCATED HEMOGLOBIN?

The FDA product code for IMX(R) GLYCATED HEMOGLOBIN 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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