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FDA 510(k)

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

K-Number: K072686 · 2008-03-17

ApplicantAxis-Shield Diagnostics, Ltd.
Decision Date2008-03-17
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS 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 2008-03-17 under 510(k) number K072686. 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 AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS?

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS is a medical device that received FDA 510(k) clearance on 2008-03-17. The listed applicant is Axis-Shield Diagnostics, Ltd.. The 510(k) number is K072686.

When did AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS receive FDA 510(k) clearance?

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS received FDA 510(k) clearance on 2008-03-17, under 510(k) number K072686.

Who is the listed applicant for AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS?

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 AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS?

The FDA product code for AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS 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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