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FDA 510(k)

GLYCA-DIRECT FRUCTOSAMINE

K-Number: K023654 · 2003-05-02

ApplicantPolymedco, Inc.
Decision Date2003-05-02
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCA-DIRECT FRUCTOSAMINE is the device name listed in this FDA 510(k) record. The listed applicant is Polymedco, Inc.. It received FDA 510(k) clearance on 2003-05-02 under 510(k) number K023654. 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 GLYCA-DIRECT FRUCTOSAMINE?

GLYCA-DIRECT FRUCTOSAMINE is a medical device that received FDA 510(k) clearance on 2003-05-02. The listed applicant is Polymedco, Inc.. The 510(k) number is K023654.

When did GLYCA-DIRECT FRUCTOSAMINE receive FDA 510(k) clearance?

GLYCA-DIRECT FRUCTOSAMINE received FDA 510(k) clearance on 2003-05-02, under 510(k) number K023654.

Who is the listed applicant for GLYCA-DIRECT FRUCTOSAMINE?

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

What is the FDA product code for GLYCA-DIRECT FRUCTOSAMINE?

The FDA product code for GLYCA-DIRECT FRUCTOSAMINE 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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