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FDA 510(k)

ATAC HEMOGLOBIN A1C REAGENT KIT

K-Number: K031042 · 2003-11-03

ApplicantClinical Data, Inc.
Decision Date2003-11-03
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ATAC HEMOGLOBIN A1C REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Data, Inc.. It received FDA 510(k) clearance on 2003-11-03 under 510(k) number K031042. 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 ATAC HEMOGLOBIN A1C REAGENT KIT?

ATAC HEMOGLOBIN A1C REAGENT KIT is a medical device that received FDA 510(k) clearance on 2003-11-03. The listed applicant is Clinical Data, Inc.. The 510(k) number is K031042.

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

ATAC HEMOGLOBIN A1C REAGENT KIT received FDA 510(k) clearance on 2003-11-03, under 510(k) number K031042.

Who is the listed applicant for ATAC HEMOGLOBIN A1C REAGENT KIT?

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

What is the FDA product code for ATAC HEMOGLOBIN A1C REAGENT KIT?

The FDA product code for ATAC HEMOGLOBIN A1C REAGENT KIT 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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