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FDA 510(k)

ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C

K-Number: K121842 · 2012-12-12

ApplicantAxis-Shield Diagnostics, Ltd.
Decision Date2012-12-12
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics, Ltd.. It received FDA 510(k) clearance on 2012-12-12 under 510(k) number K121842. 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 ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C?

ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C is a medical device that received FDA 510(k) clearance on 2012-12-12. The listed applicant is Axis-Shield Diagnostics, Ltd.. The 510(k) number is K121842.

When did ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C receive FDA 510(k) clearance?

ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C received FDA 510(k) clearance on 2012-12-12, under 510(k) number K121842.

Who is the listed applicant for ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C?

The FDA 510(k) record lists Axis-Shield Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C?

The FDA product code for ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT 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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