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FDA 510(k)

HEMOGLOBIN A1C REAGENT SET

K-Number: K051200 · 2005-08-08

ApplicantTeco Diagnostics
Decision Date2005-08-08
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN A1C REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 2005-08-08 under 510(k) number K051200. 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 HEMOGLOBIN A1C REAGENT SET?

HEMOGLOBIN A1C REAGENT SET is a medical device that received FDA 510(k) clearance on 2005-08-08. The listed applicant is Teco Diagnostics. The 510(k) number is K051200.

When did HEMOGLOBIN A1C REAGENT SET receive FDA 510(k) clearance?

HEMOGLOBIN A1C REAGENT SET received FDA 510(k) clearance on 2005-08-08, under 510(k) number K051200.

Who is the listed applicant for HEMOGLOBIN A1C REAGENT SET?

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

What is the FDA product code for HEMOGLOBIN A1C REAGENT SET?

The FDA product code for HEMOGLOBIN A1C REAGENT SET is LCP.

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Related Devices (Code: LCP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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