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FDA 510(k)

MODIFICATION TO AVIE A1C TEST SYSTEM

K-Number: K091400 · 2009-06-11

ApplicantMec Dynamics Corp
Decision Date2009-06-11
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO AVIE A1C TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mec Dynamics Corp. It received FDA 510(k) clearance on 2009-06-11 under 510(k) number K091400. 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 MODIFICATION TO AVIE A1C TEST SYSTEM?

MODIFICATION TO AVIE A1C TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2009-06-11. The listed applicant is Mec Dynamics Corp. The 510(k) number is K091400.

When did MODIFICATION TO AVIE A1C TEST SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO AVIE A1C TEST SYSTEM received FDA 510(k) clearance on 2009-06-11, under 510(k) number K091400.

Who is the listed applicant for MODIFICATION TO AVIE A1C TEST SYSTEM?

The FDA 510(k) record lists Mec Dynamics Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO AVIE A1C TEST SYSTEM?

The FDA product code for MODIFICATION TO AVIE A1C TEST SYSTEM is LCP.

Related Clinical Trials

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Other records listing Mec Dynamics Corp as applicant

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.

K121752AVIE TOTAL HB TEST SYSTEMK093548AVIE A1C TEST SYSTEMK081269AVIE A1C TEST SYSTEM

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.

K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical CorporationK231465Q-Pad Test SystemQurasenseK214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies ASK192987Aina HbA1c Monitoring System 2Jana Care, Inc.K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.K183230OneDraw A1C Test SystemDrawbridge Health, Inc.

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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