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FDA 510(k)

ARKIT HBA1C

K-Number: K030553 · 2003-09-02

ApplicantArkray, Inc.
Decision Date2003-09-02
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ARKIT HBA1C is the device name listed in this FDA 510(k) record. The listed applicant is Arkray, Inc.. It received FDA 510(k) clearance on 2003-09-02 under 510(k) number K030553. 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 ARKIT HBA1C?

ARKIT HBA1C is a medical device that received FDA 510(k) clearance on 2003-09-02. The listed applicant is Arkray, Inc.. The 510(k) number is K030553.

When did ARKIT HBA1C receive FDA 510(k) clearance?

ARKIT HBA1C received FDA 510(k) clearance on 2003-09-02, under 510(k) number K030553.

Who is the listed applicant for ARKIT HBA1C?

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

What is the FDA product code for ARKIT HBA1C?

The FDA product code for ARKIT HBA1C 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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