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FDA 510(k)

ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS

K-Number: K081895 · 2009-01-08

ApplicantSiemens Medical Solutions Diagnostics
Decision Date2009-01-08
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions Diagnostics. It received FDA 510(k) clearance on 2009-01-08 under 510(k) number K081895. 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 ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS?

ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS is a medical device that received FDA 510(k) clearance on 2009-01-08. The listed applicant is Siemens Medical Solutions Diagnostics. The 510(k) number is K081895.

When did ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS receive FDA 510(k) clearance?

ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS received FDA 510(k) clearance on 2009-01-08, under 510(k) number K081895.

Who is the listed applicant for ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS?

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

What is the FDA product code for ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS?

The FDA product code for ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS 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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