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FDA 510(k)

POLYMEDCO HBA1C TEST

K-Number: K020532 · 2002-04-24

ApplicantPolymedco, Inc.
Decision Date2002-04-24
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

POLYMEDCO HBA1C TEST is the device name listed in this FDA 510(k) record. The listed applicant is Polymedco, Inc.. It received FDA 510(k) clearance on 2002-04-24 under 510(k) number K020532. 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 POLYMEDCO HBA1C TEST?

POLYMEDCO HBA1C TEST is a medical device that received FDA 510(k) clearance on 2002-04-24. The listed applicant is Polymedco, Inc.. The 510(k) number is K020532.

When did POLYMEDCO HBA1C TEST receive FDA 510(k) clearance?

POLYMEDCO HBA1C TEST received FDA 510(k) clearance on 2002-04-24, under 510(k) number K020532.

Who is the listed applicant for POLYMEDCO HBA1C TEST?

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 POLYMEDCO HBA1C TEST?

The FDA product code for POLYMEDCO HBA1C TEST 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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