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FDA 510(k)

ABBOTT VISION(TM) GLYCATED HB

K-Number: K904027 · 1991-02-07

ApplicantAbbott Laboratories
Decision Date1991-02-07
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ABBOTT VISION(TM) GLYCATED HB is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1991-02-07 under 510(k) number K904027. 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 VISION(TM) GLYCATED HB?

ABBOTT VISION(TM) GLYCATED HB is a medical device that received FDA 510(k) clearance on 1991-02-07. The listed applicant is Abbott Laboratories. The 510(k) number is K904027.

When did ABBOTT VISION(TM) GLYCATED HB receive FDA 510(k) clearance?

ABBOTT VISION(TM) GLYCATED HB received FDA 510(k) clearance on 1991-02-07, under 510(k) number K904027.

Who is the listed applicant for ABBOTT VISION(TM) GLYCATED HB?

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 VISION(TM) GLYCATED HB?

The FDA product code for ABBOTT VISION(TM) GLYCATED HB is LCP.

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Related Devices (Code: 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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